Director, Clinical Pharmacology

Vertex Inc.Boston, MA
2d$200,000 - $300,000Remote

About The Position

The Director, Clinical Pharmacology leads strategic, scientific and operational aspects at a program level. This role represents the department on strategic and operational cross-functional program teams and will be responsible for the development of clinical pharmacology plans; assists in departmental management through program reviews and collaborative decision-making; supervises asset leads, provides career development; routinely co-leads cross-functional efforts and leads department initiatives.

Requirements

  • Knowledge expert in Clinical Pharmacology
  • Effective leadership skills to drive performance and provide career development opportunities to staff
  • Critical thinking skills, with keen scientific and development judgment
  • Experience planning and executing Clinical Development Plans for new clinical entities particularly as it applies to the discipline of Clinical Pharmacology
  • Experience conducting and supervising clinical studies such as drug-drug interaction, special population or bioavailability
  • Experience conducting and supervising non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses
  • Experience with a range of clinical studies including first-in-human, proof-of-concept and registrational studies
  • Experience contributing to clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondence
  • Experience working on teams and in a matrix environment
  • Ph.D. or Pharm D (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 10+ years of relevant post-doctoral employment experience, or Masters Degree (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 15+ years of relevant employment experience
  • Typically requires 3 years of supervisory/management experience

Responsibilities

  • Guides metabolic, co-dosing and drug-drug interaction issues, collaborating closely with cross functional colleagues
  • Co-leads or serves on cross-functional committees and/or contributes to or leads departmental initiatives
  • Creates protocol concepts and guides protocol start-up including site initiations and investigator meetings
  • Oversees and contributes to regulatory and safety documents
  • Contributes to clinical pharmacology summary documents
  • Guides PK analyses
  • Performs PK/PD or exploratory analyses and guides PK/PD modeling or simulations as appropriate
  • Provides management and career development to staff
  • Assists in recruitment and hiring
  • As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff

Benefits

  • This role is eligible for an annual bonus and annual equity awards.
  • Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
  • At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
  • From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

Number of Employees

501-1,000 employees

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