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Job Locations US-MO-St. Louis
Posted Date 15 hours ago(5/26/2022 10:21 AM)
Position Summary: The Scientist, Biology focuses on the design, development, and execution of, cellular/ immunological flow cytometry-based assays that are critical for the company to meet its goals. In this position, you will participate in both internal or contract drug discovery and biological research, addressing complex scientific questions in a fluid team environment. Efficient and effective execution is critical. Essential Duties and Responsibilities: - Hands-on laboratory researcher focused in drug discovery - Effectively carry out assays in the areas of cell biology/ immunology, with a focus on multicolor flow cytometry-based laboratory experiments. - Devise, design and execute experimental protocols using standard in-house methods, methods from partner companies or from the literature - Define the necessary reagents and supplies to conduct the desired assay; ensure that the necessary equipment is available to conduct the assay. - Assay execution, data analysis and effective oral and written communication of results including interpretation of findings and suggested next steps – both internally and to clients - Report writing and preparation of slide decks Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Required Education and Experience: - S in relevant scientific field with 5+ years relevant experience in drug discovery Preferred Education and Experience: - M.S. in relevant scientific field with 2+ years relevant experience in drug discovery Required Knowledge, Skills, Abilities & Behaviors: - Proficiency in the design and execution of assays including several of the following: - Plate based assays/medium to high throughput screening - Complex multi-parametric flow cytometry assays (including data analysis using software like FlowJo) - Mammalian cell culture and cell-based assays - Ability to organize time and work independently - Critical thinking and data interpretation skills - Ability to work in a team environment - Multitasking capabilities and interest in working in an environment with quickly changing responsibilities - Excellent oral and written communication skills - Ability to handle confidential material Work Conditions: - This position requires a significant amount of time in a laboratory environment, wearing the appropriate level of Personal Protective Equipment - The remaining time will be spent at a computer or in meetings in a relaxed office environment - Limited travel to client locations and/or parent company location may be required. Physical Demands: While performing the duties of this job, the employee is occasionally required to stand; walk; use hands and fingers, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell. The employee must occasionally lift and/or move objects up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.   The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2022-1384
Job Locations US
Posted Date 4 weeks ago(4/29/2022 9:49 AM)
Position Summary:  The Clinical Pharmacology Intern is responsible for learning the basics of Pharmacokinetics (PK) and Pharmacodynamics (PD) in clinical research. The goal of this program is to introduce students to the function, methods, and value of clinical pharmacology in the design and execution of a clinical trial.   Approximately 10-30 hours per week, on a steady basis for 3-6 months. Work hours flexible- need to complete assigned tasks. Stipend will be provided – paid internship $15-$20 dollars per hour.  Essential Duties and Responsibilities: - This is an internship position to work in research and development in a pharmaceutical company, directly with a high performing pre-clinical and clinical research team - The intern will help review and analyze clinical trial data, participate in writing and editing clinical trial documents, conduct literature search, compile data, and present reports - Intern will work under the supervision and guidance of an experienced clinical pharmacologist Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.   Required Education and Experience: - Bachelor’s degree in a science field, with concentration in biology/related field. Preferred Education and Experience: - Graduate school experience in pharmacology or Pharmacy school training preferred. - Prior research experience with drug absorption/distribution/metabolism/elimination. Required Knowledge, Skills, Abilities & Behaviors: - Deep interest in learning pharmaceutical research and drug development process - Professional demeanor with ability to communicate and deliver on a timely manner - Ability to self-motivate and learn new skills effectively - Confidentiality will be required Work Conditions: - This role routinely uses standard office equipment such as computers and phones. - This position is required to work occasional nights and weekends to meet company demands. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear.    The employee must occasionally lift and/or move objects up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.    The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.  
Job ID
2022-1383
Job Locations US
Posted Date 4 weeks ago(4/29/2022 9:49 AM)
Position Summary:  The Drug Metabolism and Pharmacokinetics Intern is responsible for learning the basics of Physiology Based Pharmacokinetics (PBPK) in pre-clinical and clinical research. The goal of this program is to introduce students to the concept, method, and value of PBPK modeling in the design and execution of a clinical trial.   Approximately 10-30 hours per week, on a steady basis for 3-6 months. Work hours flexible- need to complete assigned tasks. Stipend will be provided – paid internship $15-$20 dollars per hour.  Essential Duties and Responsibilities: - This is an internship position to work in research and development in a pharmaceutical company, directly with a high performing pre-clinical and clinical research team - The intern will help design and develop Physiology Based Pharmacokinetics (PBPK) Model for novel therapeutic candidates, conduct literature search, compile data and present reports - Intern will work under the supervision and guidance of an experienced researcher Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.   Required Education and Experience: - Bachelor’s degree in a science field, with concentration in biology/related field. Preferred Education and Experience: - Graduate school experience in pharmacology or Pharmacy school training preferred. - Prior research experience with drug absorption/distribution/metabolism/elimination. Required Knowledge, Skills, Abilities & Behaviors: - Deep interest in learning pharmaceutical research and drug development process - Professional demeanor with ability to communicate and deliver on a timely manner - Ability to self-motivate and learn new skills effectively - Confidentiality will be required Work Conditions: - This role routinely uses standard office equipment such as computers and phones. - This position is required to work occasional nights and weekends to meet company demands. Example: - This job operated in a professional office environment. - This role routinely uses standard office equipment such as computers, phones and photocopiers. - This position is required to work occasional nights and weekends to meet company demands. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear.    The employee must occasionally lift and/or move objects up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.    The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.  
Job ID
2022-1382
Job Locations US-PA-Wayne
Posted Date 2 months ago(3/30/2022 12:05 PM)
Position Summary:  The Clinical Data Manager will be responsible for providing comprehensive data management expertise (including all operations tasks and Data Management Plan generation, oversight and approval) while overseeing data management activities to ensure that the Project Team expectations are understood, timelines are met, and quality data delivered.   Essential Duties and Responsibilities: - Manage all aspects of the clinical trial data management process from study start-up to database lock for Aclaris’s clinical trials. - Serve as a member of Clinical Study Teams and act as primary Data Management contact and contributor for assigned projects. - Oversee CROs, EDC vendors and other third-party vendors in a project manager capacity in support of timelines and data-related deliverables. - Monitor timelines and ensures that clinical data management deadlines are met with quality. - Perform UAT for database and test according to UAT Plan. - Specify requirements for data management documentation, electronic and manual edit checks created by CRO. - Review and approve electronic and manual edit checks created by third party vendors. - Review and approve data management documentation created and maintained by third party vendors. - Ensure that all medical coding is performed on an ongoing basis throughout the life cycle of the program and at the end prior to database lock. - Ensure the proper data transfers are conducted (central lab data, ECG data, patient reported outcome data, etc.). - Create and maintain electronic and manual edit check specifications for internal studies. - Create and maintain data management documentation for internal studies. - Oversee the review of clinical trial data to identify erroneous, missing incomplete, or implausible data. - Review and provide feedback on protocols. - Ensure adherence to data management standards. - Provide written and/or verbal status reports to department and project team. - Provide data management input to Requests for Proposal. - Review vendor proposals, work orders and contracts. - Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements. - Manage multiple projects. - Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, and input from project team members. - Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities. - Investigate, evaluate, and implement new technology solutions. Additional Responsibilities: - Participate in projects / initiatives on request or take on department-wide tasks to contribute to the optimization of processes within the department. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.   Preferred Education and Experience: - BA/BS (preferred but not required). - Minimum 5-8 years of related experience in clinical data management in the pharmaceutical / biotechnology industry or equivalent. Required Knowledge, Skills, Abilities & Behaviors: - Proficiency with web-based EDC systems experience required. - Remote Data Capture (OC/RDC) experience as well as relational database and report development experience, including basic SQL knowledge preferred. - Experience with IWRS systems required. - Have an understanding of SAS programming. - Understand SDTM and ADaM reporting requirements. - Strong leadership skills driving change and process by example strategic and critical thinking skills. - Demonstrates ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders. - Results-oriented; effective ability to set and meet short-term and long-term goals. - Strong communication, organization, and decision-making skills. - High level of agility and diplomacy. - Effective ability to handle matters objectively. - Must be able to anticipate challenges and project risks and proactively implement solutions. - Strong time management and effective planning skills. - Strong working knowledge of MS Office and Outlook. - Knowledge and understanding of regulatory guideline for use of computer systems in clinical studies. - Demonstrated knowledge of FDA regulations/guidelines, ICH guidelines, GCPs, and computer systems validation. Work Conditions: - Due to COVID, employees are required to work remotely but will transition back to a professional office environment. - This role routinely uses standard office equipment such as computers, phones, and photocopiers. - This position is required to work occasional nights and weekends to meet company demands. - Occasional overnight travel to investigator sites or Site Initiation Meetings may be required.   The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants foropen positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.  
Job ID
2022-1379
Job Locations US-PA-Wayne
Posted Date 2 months ago(3/30/2022 11:25 AM)
Position Summary:  The CTM is the primary operational contact for the study and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the Clinical Operations Lead when needed. The CTM is responsible for mentoring clinical research associates (CRAs) and clinical trial associates (CTAs), as appropriate.   Essential Duties and Responsibilities: - Responsible for all operational aspects and progress of clinical trial from a study planning activity to study execution including ongoing tracking all applicable performance metrics and quality indicators - Serves as an escalation point and resource for study team and investigational sites - Oversees/facilitates site feasibility/selection processes - Develops/oversees subject recruitment/retention strategy and related initiatives - Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc. - Participates in the review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate - Responsible for and participates in clinical vendor selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations) - Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages - Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct - Creates, manages, measures, and reports timelines for milestone deliverables - Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders - Oversees internal team meetings, investigator meetings, and other trial- specific meetings - Participates in the development, review, and implementation of departmental SOPs, initiatives and processes - Reviews/approves vendor invoices for all clinical trial vendors including investigative sites - Perform other work-related duties as assigned Required Education and Experience: - At least 5 years clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO). Preference to candidates with prior small company experience and 1+ years management experience - Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required - Ability to interpret data - Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results - Strong attention to detail and excellent organization skills - Strong interpersonal skills and communication skills (both written and oral) - Ability to problem solve, delegate appropriate tasks and/or develop junior team members - Excellent sense of urgency to deliver at/surpass study conduct targets - Strong leadership skills, self-motivated, adaptable to a dynamic environment - Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities - Preference to energetic candidates with a desire to think “outside the box” - Willingness to travel as needed, up to 20% Preferred Education and Experience: - Bachelor’s degree preferred. Preference to candidates with a scientific background - Immunology and/or Dermatology experience a plus Required Knowledge, Skills, Abilities & Behaviors: Strong GCP and ICH guideline knowledge base; ability to multi-task; ability to manage a team of clinical research professionals working on a clinical trial program; strong communication skills; flexibility   Work Conditions: - This job operated in a professional office environment - This role routinely uses standard office equipment such as computers, phones and photocopiers - This position is required to work occasional nights and weekends to meet company demands   Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   Occasional travel is required via automobile, train, bus and/or airplane   While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell.   The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.     The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants foropen positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2022-1377
Job Locations US-PA-Wayne
Posted Date 2 months ago(3/30/2022 11:23 AM)
Position Summary:  The CTA provides broad support to the Clinical Operations team and assists in operational delivery of clinical studies.   Essential Duties and Responsibilities: - Collecting, registering, and archiving information and documents in accordance with the applicable GCP guidelines for clinical studies and corresponding Aclaris Standard Operating Procedures. - Maintenance of Trial Master File (TMF) and Investigator Site Files (ISF) to ensure regulatory compliance and audit readiness. - Collection and tracking of regulatory documents for study start-up and IRB submissions; provide oversight of Contract Research Organization (CRO) managed studies to ensure these activities are completed. - Assist in the preparation of study documentation forms, and the development of administrative and filing systems and processes. - Accountable for the management of study materials and supplies - distribution, ordering, tracking, storage, reconciliation, and destruction. - Assist in the planning, preparation, and presentation of Site Initiation Meetings. - Maintain study contact list(s) for all clinical trial sites and vendors. - Assist Clinical Operations in tracking study related activities. - Assist in the preparation/review of study documents and communications for designated projects, including internal and external correspondence. - Track the progress of clinical trial including patient recruitment, trial supplies and trial documentation. - Track and process invoices and authorize clinical trial payments to selected vendors and investigational sites, accurately and in a timely manner. - Organize and schedule appointments/meetings, internally and externally, as necessary and prepare meeting minutes. - Complete assigned tasks in accordance with GCP, ICH guidelines and other regulatory requirements for clinical trial management. - Other duties as assigned. Additional Responsibilities: - Participate in projects / initiatives on request or take on department-wide tasks to contribute to the optimization of processes within the department. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.   Preferred Education and Experience: - BA/BS (preferred but not required) - Minimum 1 to 2 years CTA experience - Previous biopharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO. Required Knowledge, Skills, Abilities & Behaviors: - Excellent oral and written communication skills, attention to detail and ability to interact effectively with internal management and various levels of external partners. - Ability to manage multiple priorities and responsibilities. - Working knowledge of FDA regulations/guidelines, ICH guidelines and GCPs. - Demonstrate understanding of trial and protocol objectives. - Strong working knowledge of MS Office and Outlook. - Proficient with Veeva eTMF (preferred but not required). Work Conditions: - Due to COVID, employees are required to work remotely but will transition back to a professional office environment. - This role routinely uses standard office equipment such as computers, phones, and photocopiers. - This position is required to work occasional nights and weekends to meet company demands. - Occasional overnight travel to investigator sites or Site Initiation Meetings may be required. The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants foropen positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2022-1376
Job Locations US-PA-Wayne | US | US-MO-St. Louis | US-MO-St. Louis
Posted Date 3 months ago(2/17/2022 1:25 PM)
Position Summary:    The Vice President, Clinical Development will be responsible for providing strategic and operational leadership regarding the Company’s clinical development programs. The Vice President, Clinical Development will oversee the development and implementation of the Company’s clinical programs and be responsible for Pharmacovigilance.   Essential Duties and Responsibilities:   - Develop and implement the clinical development strategy for clinical development programs - Oversee clinical development activities including review of clinical documents (e.g., briefing documents, manuscripts, submission documents) for regulatory submissions - Develop Clinical Research strategy for the programs they lead - Manage Pharmacovigilance including strategy and the management of PV Regulatory reporting. - Provide medical expertise and input to various functions including Corporate Affairs, Business Development, Legal, Research, Pharmacovigilance - Oversee the implementation of the clinical development strategy and plans to achieve Company objectives regarding the timing and execution of the Company’s clinical development programs - Participate in clinical data analysis preparation of reports - Act as a liaison with academic and industry thought leaders to optimize the Company’s clinical development programs - Act as a medical resource for internal and external stakeholders regarding the Company’s products - Provide medical input for Company medical and corporate communications - Collaborate with Regulatory Affairs, Project Management, Toxicology, Research & Drug Discovery, and Legal departments to ensure Clinical development strategies and activities are aligned with corporate objectives - Provide medical input for Company asset and company acquisitions Other Duties:   Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.   Required Education and Experience: - Physician (MD or DO) with appropriate pharmaceutical or biotech experience - Established track record of development and successful execution of clinical development strategies and programs - Proven track record as a member of a senior management or Executive Team - A solid background in all phases of clinical development, including the following: - Established track record of successful execution of clinical trials from Phase I through Phase III; (Phase IV a plus) - Knowledge of clinical elements of IND and NDA submissions - Development and execution of clinical program budgets and timelines Preferred Education and Experience:   - Immuno-inflammation and/or Rheumatology experience is a plus, but not required Required Knowledge, Skills, Abilities & Behaviors: - Strategic and innovative thinker - Excellent communication, management, organizational and interpersonal skills - Excellent analytical skills Work Conditions:   - This job operates in a professional office environment. - This role routinely uses standard office equipment such as computers, phones and photocopiers. - This position is required to work occasional nights and weekends to meet company demands.   Physical Demands:   The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear.    The employee must occasionally lift and/or move objects up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.    The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2022-1369
Job Locations US-PA-Wayne
Posted Date 4 months ago(2/4/2022 12:13 PM)
Position Summary:  The Director of Product Leadership is responsibility for all aspects relating to a Project’s drug development. They will lead a cross matrix team consisting of members from all functions necessary to develop a drug of clinical and commercial value.   They will work across the organization and are responsible for the strategy and execution of high quality, on budget plans that deliver against that strategy.   Essential Duties and Responsibilities: - Oversees Project Teams to develop a Project Strategy to deliver a medicine that addresses the needs of the stakeholders: patients, physicians, payors, and Steering Committee - Develops an annual and long-term plan agreed with the Steering Committee that delivers that strategy - Responsible for delivery of the plan: on time, on budget and to high quality - Matrix manages Project Team members – sets clear objectives, monitors, and manages performance and participates in formal performance assessments - Responsible for all aspects of the Project from IND through late-stage clinical development - Responsible for the ethical conduct of project activities and ensures high quality delivery Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.   Required Education and Experience: - B.S. Degree in scientific related field required. - M.S. Degree in scientific related field preferred. Required Knowledge, Skills, Abilities & Behaviors: - Minimum of 10 years’ experience in drug development within the pharmaceutical industry. - Leader of people. - Strong understanding of the drug development process. - Strong understanding of the dynamics of Companies, Regulatory agencies and external customers. - Demonstrated ability to work both independently and as part of a multidisciplinary team. - Strong verbal and written communication. - Detail oriented with good organizational skills. - Excellent written and verbal communication skill to collaborate well internally and externally. Work Conditions: - This job operated in a professional office environment. - This role routinely uses standard office equipment such as computers, phones and photocopiers. - This position is required to work occasional nights and weekends to meet company demands.   Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   Occasional travel is required via automobile, train, bus and/or airplane.   While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell.   The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.   The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2022-1368
Job Locations US-PA-Wayne | US-MO-St. Louis | US-MO-St. Louis
Posted Date 4 months ago(1/31/2022 5:33 PM)
Position Summary: The Director of Analytical Sciences reports to the Senior Vice President of Research and  Pharmaceutical Development (or Sr. Director of Pharmaceutical Development) and will serve as a subject matter expert in analytical sciences for Aclaris drug development programs. This position is responsible for oversight of all outsourced analytical development activities including method development, validation and technology transfer for starting materials, intermediates, active pharmaceutical ingredients and drug products by providing operational, scientific, and technical leadership for all development programs.  With a primary focus on early to mid-staged clinical development assets, the position will also support compounds transitioning from discovery to early development.   Essential Duties and Responsibilities: - Direct phase appropriate analytical method development, technology transfer, and validation for both drug substance and drug product. - Review and approve vendor analytical methods, validation protocols, and stability protocols. - Direct drug substance physicochemical and solid-state property characterization including crystallinity assessment, solubility determination, and stability evaluation to aide in selection of candidates and development that will lead to drug products with desirable physicochemical and pharmacokinetic properties. - Oversee drug substance and drug product testing and stability. - Author phase appropriate specifications and stability protocols for drug substance and drug product, and CMC regulatory documents including INDs, NDAs, and IMPDs. - Work with Project Management and Leadership to develop and manage detailed budgets and timelines for multiple programs. - Work closely with Regulatory Affairs and Quality Assurance to ensure compliance with all local, state, federal and international regulations during product development. - Build and maintain strong working relationships with CRO/CDMO/CMO partners ensuring that activities are managed collaboratively, efficiently, and effectively. Be on-site, as necessary. - Maintain high scientific and technical standards for all development activities and documentation in accord with corporate and departmental SOPs. - Contribute to drug product regulatory strategy development through Project Team participation and contribution to components of regulatory filings. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.   Required Education and Experience: - BS/MS in a related scientific discipline and 15 years of experience or a Ph.D. with 10 years of experience in the pharmaceutical industry - Expertise in analytical method development, technology transfer and validation for drug substance, drug product, and bioanalytical methods. - Established knowledge of phase appropriate pharmaceutical analytical development and overall R& D process. - Demonstrated ability to work both independently and as part of a multidisciplinary team. - Adaptability and positive attitude in a fast-paced environment. - Experience with small molecules & development of oral, and topical dosage forms. - Excellent written and verbal communication skills and ability to collaborate both internally and with contracted vendor services. Work Conditions: - This job operated in a professional office environment. - This role routinely uses standard office equipment such as computers, phones and photocopiers. - This position is required to work occasional nights and weekends to meet company demands.   Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   Occasional travel is required via automobile, train, bus and/or airplane    While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell.     The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.     The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.   
Job ID
2022-1366
Job Locations US
Posted Date 7 months ago(11/3/2021 4:37 PM)
Position Summary:  The Senior Director Toxicology works closely with the VP of Toxicology for the design, conduct, interpretation, and reporting of nonclinical safety assessment studies for Aclaris’s drug candidates including general toxicology and toxicokinetic, genetic toxicology, safety pharmacology, reproductive toxicology, carcinogenicity, juvenile toxicity and other safety-related preclinical studies required for certain compounds (for example phototoxicity assessments, sensitization ocular toxicity, etc.).  Directs study of practical application of toxicological research as part of multidisciplinary drug development teams to develop investigational drug products from development candidate selection to NDA.  As a member of the Development Team, provides input to establish research priorities, resourcing and management of the development programs. This position will work closely with discovery research, clinical, regulatory, PDM, project management and manufacturing and advise project teams and management on the non-clinical safety aspects of all development projects and take part in communicating with domestic and foreign regulatory agencies.   Essential Duties and Responsibilities: - Responsible for the study of investigational new drugs as it pertains to toxicology and other safety studies as needed. - Work closely with Discovery Research for early discovery phase safety studies to support development candidate nomination. - Works closely with Manufacturing and formulation development to ensure drug supply/re-supply for all non-clinical studies to support project timelines. - Provide project specific support to resolve toxicology issues, as required. - Work with Chemistry, Manufacturing, and Controls (CMC) to address impurity-related issues for regulatory needs and to manufacture GLP supplies for pre-clinical studies - Design, implement, interpret, and report phase appropriate toxicology/Toxicokinetic studies. - Work as part of a development team and actively participate in team strategy discussions for drug development programs - Preparation of preclinical documents for worldwide regulatory submissions, including authoring the nonclinical safety summaries of regulatory dossiers (e.g. IDB, INDs, NDAs, MAAs) and to prepare written responses to inquiries from regulatory agencies - Effectively oversee and manage Contract Research Organizations (CROs) and vendors used for Toxicology studies for Aclaris’s projects - Present key findings and influence thinking of program teams, R&D leadership, and regulatory authorities - Resolve conflicts impacting non-clinical studies and development milestones. - Proactively identify and communicate study timelines to all key stakeholders on the project. - Review existing applicable SOPs and identify the need for and assist with SOP development, as required. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.   Required Education and Experience: - PhD in pharmacology/toxicology or related discipline plus a minimum of 10 years’ experience (or MS plus a minimum of 15 years’ experience) with the conduct and submission of nonclinical safety evaluation studies in the biotech/pharmaceutical industries. Preferred Education and Experience: - Board certification (DABT) is desirable, but not required   Required Knowledge, Skills, Abilities & Behaviors: - Strong knowledge of toxicology, safety pharmacology, drug metabolism, and toxicokinetic - Strong interpersonal skills and ability to effectively manage external consultants and third-party CROs - Strong problem solver who is highly organized with the ability to lead in an environment with rapidly changing priorities - Demonstrated ability to work both independently and as part of a multidisciplinary team to contribute to the successful development of pharmaceutical drug products on time. - Knowledge of relevant regulatory guidelines, requirements, and standards (GLP, OECD, ICH, CTD, and US FDA guidance’s) and be able to develop nonclinical toxicology strategies that support all phases of clinical development - Broad understanding of nonclinical safety evaluation and drug development, (dermatology experience a plus) - Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, analytical methods, toxicology, and pathology assessing the clinical relevance and impact - Experience with in vitro assays utilized for assessment of toxicological risks - Experience authoring nonclinical toxicology components of regulatory dossiers and interacting with US and worldwide regulatory agencies - Hands-on experience in design and management of non-clinical toxicology studies in support of regulatory applications - Detail oriented with good organizational skills. - Ability to work independently and possess exceptional attention to detail - Ability to contract with CROs and maintain project related budgets - Excellent written and verbal communication skills to collaborate well internally and externally Work Conditions: - This job operated in a professional office environment. - This role routinely uses standard office equipment such as computers, phones and photocopiers. - This position is required to work occasional nights and weekends to meet company demands. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.   Occasional travel is required via automobile, train, bus and/or airplane.   While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell.   The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.   The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2021-1363
Job Locations US-PA-Wayne
Posted Date 7 months ago(10/11/2021 10:33 AM)
Position Summary: The Director/Senior Director Nonclinical Drug Development reports to the Vice President Toxicology and is responsible for the design, conduct, interpretation and reporting of nonclinical drug development studies, with a working knowledge of nonclinical safety studies including general toxicology; reproductive toxicology; and carcinogenicity studies; and an strong working knowledge of ADME/PK studies including absolute bioavailability PK studies; toxicokinetic evaluation in support of nonclinical toxicology studies; metabolite identification /profiling in-vitro and in appropriate animal models and humans; tissue distribution/mass balance excretion studies in appropriate animal species; drug transporter interaction studies; CYP isozyme characterization studies; clinical formulation testing in appropriate animal species; drug-drug interactions studies; metabolic fate studies in appropriate animal species; and bioanalytical method validation to support Aclaris' drug development candidates in both the preclinical setting and the clinical setting. This is a position requiring a demonstrated ability to work independently, to support nonclinical safety activities, and to lead DMPK activities for multiple projects effectively, including a working knowledge of relevant regulatory guidelines and applicable GLP regulation. The individual has shown leadership, innovation, and collaborative ability and has demonstrated the ability to lead groups of scientists successfully. He/she is responsible for assisting management in the overall administration of the department and has working experience in managing contract research organizations (CROs). The individual is generally acknowledged to be the resident expert in his/her primary areas of expertise, both internally and externally. The position will work closely withdiscovery research, clinical, regulatory, project management and manufacturing, and advise project teams with management on the non-clinical aspects of all development projects and take part in communicating with domestic and foreign regulatory agencies.   Essential Duties and Responsibilities: - Responsible for the study of investigational new drugs as it pertains to nonclinical safety and ADME/PK, as well as other nonclinical studies as needed (e.g. mechanistic studies} - Provide leadership for nonclinical ADME/PK activities to support Aclaris' drug development programs, and support clinical development programs, as required - Work as part of a development team and actively participate in team strategy discussions for drug development program - Preparation of preclinical documents for worldwide regulatory submissions, including authoring the nonclinical summaries of regulatory dossiers (e.g. IDB, INDs, NDAs, MAA,s) and to prepare written responses to inquiries from regulatory agencies - Effectively oversee and manage Contract Research Organizations (CROs) and vendors used for nonclinical drug development studie - Supervising and/or conducting/review of pharmacokinetic/toxicokinetic data analyses and pharmacokinetic modelling/simulation, as needed, in support of nonclinical and clinical development programs - Provide input/recommendations for currently utilized technologies or new technologies that would be useful to support ongoing or future nonclinical development activities (in-house or with CRO's) - Presentskey findings and influence thinking of project teams, R&D Leadership and regulatory authorities - Resolves conflicts impactingpreclinicaldevelopmentactivitiesandkeydevelopment - Proactively identify and communicate study timelines to all key stakeholders on assigned drug developments project - Assists departmenthead, as needed, with budgetary planning, including capital equipment - Review existing applicable Standard Operating Procedures (SOPs), and identify the need for SOP development, as required  Required Education and Experience: - PhD in Pharmacokinetics/Pharmaceutical Development or related discipline - Minimum of 10 years' experience with the conduct and submission of nonclinical studies, with an emphasis on ADME/PK, in the biotech/pharmaceutical industries Required Knowledge, Skills. Abilities &Behaviors : - Strong knowledge of nonclinical development activities including drug safety, ADME/PK and toxicokinetic - Strong interpersonal skills and ability to effectively manage external consultants and third-party CROs - Strong problem solver who is highly organized with the ability to lead in an environment and rapidly changing priorities, and aggressive drug development timelines WorkConditions: - This job operated in a professional office - This role routinely uses standard office equipment such as computers, phones and - This position is required to work occasional nights and weekends to meet company Physical Demands: Thephysicaldemandsdescribedherearerepresentativeofthosethatmustbe met by an employee to successfully perform the essential functions of this job.   Occasional travel is required via automobile, train, bus and/or airplane.   While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell.   The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.   The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2021-1358
Job Locations US-MO-St. Louis
Posted Date 12 months ago(6/10/2021 12:25 PM)
  Position Summary:  This position is for an independent key scientific leader, involved in setting scientific direction within the Biochemistry group and across the organization.  In this role you will enable advancement of internal and external projects through both hands on execution and guidance of others; mentorship of junior and senior scientists is expected.  The ability to develop and implement innovative approaches to novel research problems is key for this position.  Efficient and effective communication within the organization and with clients is critical.   Essential Duties and Responsibilities: - Provide leadership on scientific strategies both within Biochemistry and across drug discovery disciplines - Planning, design, execution and management of internal and external projects - Development of junior and senior scientists - Ensure Confluence remains state of the art in field of biochemistry / enzymology both from a strategic and operational standpoint - Expand customer base through contacts and effective communication of Confluence capabilities Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.   Required Education and Experience: - D. with 15+ years of experience or B.S./M.S. scientist with 20+ years relevant drug discovery experience Required Knowledge, Skills, Abilities & Behaviors: - Externally recognized scientific contributor in field of expertise - Expertise in interrogating drug:target interactions via mechanistic enzymology, target engagement studies, and/or biophysical techniques - Demonstrated ability to set technical scientific strategy within biochemistry / enzymology; working understanding of relevant drug discovery and development processes in related disciplines - Demonstrated ability to mentor and develop junior and senior scientists - Ability to prioritize and address highest impact, project related issues - Ability to independently design, develop and execute new approaches and effectively apply traditional approaches to biochemical drug discovery - Work across lines, interface effectively with project teams, chemistry leadership, company management and customers - Effectively communicate complex data and concepts to the broader organization, scientific community, investors, and other stakeholders Work Conditions: - This position is in a laboratory and casual office environment.   Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand, walk, use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear.  The employee must occasionally lift and/or move objects up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.      The safety and well-being of our employees during the pandemic has been and continues to be a top priority. Toward that end, and based on the latest recommendations of scientists and health officials that the COVID-19 vaccine provides the best protection against severe infection, we are requiring that all successful applicants for open positions at all of our office locations must be fully vaccinated against COVID-19 as a condition of employment. Accommodations may be made in accordance with applicable law.
Job ID
2021-1354
Job Locations US-MO-St. Louis
Posted Date 1 year ago(5/5/2021 6:39 PM)
Position Summary:  Reports to the VP of Chemistry and works closely with scientific leadership of other disciplines with a strong emphasis on expertise in synthetic chemistry, medicinal chemistry and PDM.  The Associate Fellow is responsible for setting strategy within the discipline and participating on the team with executive leadership to establish and execute on short and long-term company goals.  Additionally, this position will effectively mentor and set direction of scientific staff, development of junior and senior scientists and effective resourcing of projects with a broad portfolio view.  As a recognized scientific expert in Medicinal Chemistry and Drug Development, lead projects and teams guiding the expansion of research directions in line with projected industry direction.
Job ID
2021-1350
Job Locations US-MO-St. Louis
Posted Date 1 year ago(5/5/2021 6:25 PM)
Position Summary: The Principal Scientist in DMPK is an independent drug discovery scientist who focuses on the design and execution of projects in their area of expertise.  This position will capitalize on recognized expertise in DMPK and bioanalytical analysis in the context of drug discovery.  In this position, you will independently drive focused internal and contract drug discovery research as part of a team of scientists, addressing complex scientific questions in a fluid team environment.  Efficient and effective execution is critical.
Job ID
2021-1349