Director, Clinical Pharmacology

Director, Clinical Pharmacology page is loaded## Director, Clinical Pharmacologylocations:
Boston, MAtime type:
Full time posted on:
Posted Todayjob requisition :
REQ-28155
** Job Description
**** General

Summary:

** The Clinical Pharmacology Director 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.
** Key

Duties and Responsibilities:

*** Leverage clinical quantitative pharmacology skills to advance and support Vertex programs
* 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
** Knowledge and

Skills:

*** Subject matter expert in Clinical Pharmacology with experience in small molecules, biologics, or other modalities.
* Effective leadership skills to drive performance and provide career development opportunities to staff.
* Critical thinking skills, with keen scientific and development judgment.
* Broad experience in applying clinical pharmacology and dose optimization strategies for Phase II/III studies and regulatory submissions.
* 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, thorough QT studies, or bioavailability.
* Experience conducting and supervising non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses.
* Hands on expertise in data analysis using Phoenix Win Nonlin, R, and NONMEM.
* 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.
*
* Education and Experience:

*** 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#LI-KM4
** Pay Range:**$200,000 - $300,000
** Disclosure Statement:
** The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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…