Vice President, Clinical Development

Job Locations US-PA-Wayne
Posted Date 3 months ago(4/8/2021 1:34 PM)
Job ID
2021-1344
# of Openings
1
Category
Clinical

Overview

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.

Responsibilities

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.

 

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.

 

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.

 

Qualifications

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

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