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Job Locations US-PA-Wayne
Posted Date 1 week ago(6/16/2021 5:09 PM)
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 4 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.  
Job ID
2021-1356
Job Locations US-PA-Wayne
Posted Date 2 weeks ago(6/10/2021 12:40 PM)
  JOB DESCRIPTION Position:         Associate Director, Clinical Pharmacology Location:         Wayne Reports to:     Edward Hellriegel, Director, Non-Clinical Development R&D Direct Reports:  None Department:    Non-Clinical Drug Development Hours of Work:  40 Classification:  Exempt Travel: 0-25%   Position Summary:    The Associate Director, Clinical Pharmacology position reports to the Director, Non-Clinical Development  R&D having the following responsibilities. The candidate will be working primarily to support development projects in Immuno-inflammatory/Oncology diseases, including the design, implementation, and reporting of clinical pharmacology studies (DDI, TQT, hepatic/renal insufficiency, BA/BE, etc.) based on applicable regulatory requirements. These activities include establishing PK/PD clinical plans, performing PK/PD analysis, authoring clinical pharmacology sections of clinical study reports (CSR) and all applicable worldwide regulatory documents (IB, IND, NDA, MAA, etc.). The candidate will be responsible for designing/planning/monitoring/reporting of Clinical Pharmacology studies in collaboration with Clinical Research and Nonclinical Drug Development. The candidate will possess a significant understanding of clinical PK and PK/PD concepts and applications as well as have knowledge of drug metabolism, physiology, and human and animal studies for drug development programs. This position will work closely with clinical, nonclinical, regulatory, and project management and advise project teams and management on the clinical pharmacology programs for all development projects and take part in communicating study design and results with domestic and foreign regulatory agencies.   Essential Duties and Responsibilities:   - Responsible for the development and execution of the overall Clinical Pharmacology strategy and data interpretation of Clinical Pharmacology studies in support of drug candidates. - Responsible for the development and execution of the pharmacometrics plan in support of clinical development projects and managing external vendors sourced for conducting pharmacometric analyses (eg, population PK and PK/PD analyses, physiologically-based PK analysis, etc.). - Responsible for providing input (from a PK perspective) into clinical study protocols and reports and for preparation of the Clinical Pharmacology sections of regulatory documents (eg, IB, IND, NDA, etc.). - Responsible for managing the operational elements of Clinical Pharmacology studies. - Responsible for representing the Clinical Pharmacology function both internally (study and project teams) and externally (meetings with regulatory authorities, collaborators, external vendors). - Secondary responsibilities (as time permits) will also include supporting development projects from a nonclinical DMPK perspective.   Required Education and Experience:   - PhD in Pharmaceutical Sciences, Biopharmaceutics, Clinical Pharmacology, or other relevant life sciences and at least 5 years of industry experience in clinical pharmacology. - Experience in clinical research and working within a clinical study team. - Experience in PK analysis using standard methodologies (eg, NCA and compartmental analysis using Phoenix WinNonlin) and more advanced modeling/simulation methodologies (eg, population PK and PK/PD analyses using NONMEM, PBPK using GastroPlus). - Strong understanding of the overall drug development process both from a nonclinical and clinical perspective. - Strong oral and written communication skills, and ability to effectively manage CRO’s and external vendors for clinical and nonclinical DMPK drug development studies. - Ability to interpret PK and PK/PD results and prepare presentations to accurately and effectively communicate study results to project teams, management, and regulatory authorities. - Thorough understanding of regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines relevant to the conduct of clinical pharmacology studies (eg, drug-drug interaction, bioavailability/bioequivalence, special populations, etc.). - Assists department head, as needed, with budgetary planning, including capital equipment procurement. - Strong problem solver who has the ability to work in an environment with rapidly changing priorities and aggressive drug development timelines.  Required Knowledge, Skills, Abilities & Behaviors:   - PhD in Pharmaceutical Sciences, Biopharmaceutics, Clinical Pharmacology, or other relevant life sciences and at least 5 years of industry experience in clinical pharmacology. 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.   
Job ID
2021-1355
Job Locations US-MO-St. Louis
Posted Date 2 weeks ago(6/10/2021 12:25 PM)
JOB DESCRIPTION Position:         Associate Research Fellow Location:         St. Louis, MO Reports to:     William Taylor Direct Reports:  None Department:    Biochemistry Hours of Work:  40 Classification:  Exempt Travel: 0-10% Date:               June 09, 2021   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. 
Job ID
2021-1354
Job Locations US-PA-Wayne
Posted Date 2 weeks ago(6/7/2021 1:32 PM)
Position Summary:  Responsible for overseeing the Regulatory Affairs function of Aclaris Therapeutics.  Sets and oversees the execution of regulatory strategies for the earliest possible approvals of the company’s regulatory applications at all stages of development (e.g., phase 1 through phase 4 and post launch). Addresses the analysis and evaluation of regulatory procedures and changes on the company’s products to ensure attainment of corporate goals.   Essential Duties and Responsibilities: - Develop and implement the global Regulatory strategy for Research and Development programs - Oversee Regulatory activities including review of clinical documents for regulatory submissions - Provide Regulatory expertise and input to various functions including Corporate Affairs, Business Development, Legal, Research, Pharmacovigilance - Input to clinical development strategy and plans to achieve Company objectives regarding the timing and execution of the Company’s clinical development programs - Represents the company at Regulatory Body meetings - Collaborate with R&D, Project Management, Toxicology, Research & Drug Discovery, and Legal departments to ensure Regulatory strategies and activities are aligned with corporate objectives - Provide Regulatory input for Company asset and company acquisitions - Develops and implements strategic plans and objectives for the organization in alignment with corporate strategy; oversees direction and approves tactical administrative or operational policies and resource allocation decisions to ensure achievement of objectives. 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 with notice.   Required Education and Experience: - S. or B.A. degree required, with advanced degree in a pharmaceutical or scientific field preferred. - A minimum of 10 years of pharmaceutical industry experience including 8 years of regulatory experience or a combination of 2 years regulatory and/or related experience in drug development. Required Knowledge, Skills, Abilities & Behaviors: - Good understanding of the FDA and EMA regulated drug development process. - Experience in drug development. - Demonstrated ability to work both independently and as part of a multidisciplinary team to contribute to the preparation of high-quality submissions on time. - Strong verbal and written communication skills. - Detail oriented with good organizational skills.   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.  
Job ID
2021-1353
Job Locations US-MO-St. Louis
Posted Date 2 months 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 2 months 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
Job Locations US-PA-Wayne
Posted Date 2 months ago(4/29/2021 6:37 PM)
Position Summary:    The Associate Director, Clinical Pharmacology position reports to the Director, Non-Clinical Development  R&D having the following responsibilities. The candidate will be working primarily to support development projects in Immuno-inflammatory/Oncology diseases, including the design, implementation, and reporting of clinical pharmacology studies (DDI, TQT, hepatic/renal insufficiency, BA/BE, etc.) based on applicable regulatory requirements. These activities include establishing PK/PD clinical plans, performing PK/PD analysis, authoring clinical pharmacology sections of clinical study reports (CSR) and all applicable worldwide regulatory documents (IB, IND, NDA, MAA, etc.). The candidate will be responsible for designing/planning/monitoring/reporting of Clinical Pharmacology studies in collaboration with Clinical Research and Nonclinical Drug Development. The candidate will possess a significant understanding of clinical PK and PK/PD concepts and applications as well as have knowledge of drug metabolism, physiology, and human and animal studies for drug development programs. This position will work closely with clinical, nonclinical, regulatory, and project management and advise project teams and management on the clinical pharmacology programs for all development projects and take part in communicating study design and results with domestic and foreign regulatory agencies.
Job ID
2021-1348
Job Locations US-MO-St. Louis
Posted Date 2 months ago(4/29/2021 6:21 PM)
Position Summary:  The Principal Scientist, Biology is an independent drug discovery scientist who focuses on the design and execution of projects in their area of expertise.  This position will utilize training in biological, immunological, or other pharmacological analysis in the context of drug discovery.  In this position, you will drive focused internal and contract drug discovery and biological 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
2021-1346
Job Locations US-MO-St. Louis
Posted Date 2 months ago(4/29/2021 5:44 PM)
Position Summary: The Scientist, Biology focuses on the design, development, and execution of, cellular,immunological and/or other biological/pharmacological 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.     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.
Job ID
2021-1345
Job Locations US-PA-Wayne
Posted Date 3 months ago(4/8/2021 1:34 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.
Job ID
2021-1344
Job Locations US-PA-Wayne
Posted Date 3 months ago(4/8/2021 9:37 AM)
Position Summary The CTA provides broad support to the Clinical Operations team and assists in operational delivery of clinical studies.   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.
Job ID
2021-1342
Job Locations US-PA-Wayne
Posted Date 3 months ago(4/8/2021 9:36 AM)
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.
Job ID
2021-1341