Vertex

Biotechnology

ClinicalPharmacologyDirector

$200–300k Boston, Massachusetts, United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Clinical Pharmacology Director at Vertex. Skills: Clinical Pharmacology, Quantitative pharmacology, Drug development. Lead strategic aspects. Lead scientific aspects”

Industry & Context.

Biotechnology
Problems you'll solve

Critical thinking; Scientific judgment; Development judgment

Eligibility Requirements

Interaction with health authorities

What They're Looking For.

Must Have

10+ years post-doctoral employment experience, 15+ years relevant employment experience, 3 years supervisory/management experience, Ph. D. or Pharm D or equivalent degree, Masters Degree or equivalent degree

Nice to Have

Immunology and Autoimmune diseases therapeutic area knowledge, relevant disease knowledge

What You'll Do.

Lead strategic aspects

Lead scientific aspects

Lead operational aspects

Represent department on program teams

Supervise asset leads

Provide career development

Co-lead cross-functional efforts

Lead department initiatives

Apply clinical quantitative pharmacology strategy

Guide metabolic issues

Guide co-dosing issues

Guide drug-drug interaction issues

Collaborate with colleagues

Serve on cross-functional committees

Contribute to departmental initiatives

Create protocol concepts

Guide protocol start-up

Guide site initiations

Guide investigator meetings

Oversee regulatory documents

Contribute to regulatory documents

Oversee safety documents

Contribute to safety documents

Contribute to clinical pharmacology summary documents

Perform PK/PD analyses

Perform exploratory analyses

Guide PK/PD simulations

Provide mentorship to staff

Assist in recruitment

How You'll Work.

Team & Collaboration

Cross-functional program teams; Cross-functional committees; Matrix environment

Communication Scope

Regulatory correspondence

Process & Methodology

Clinical Development Plans

Full Job Description

**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:** * Responsible for the application of clinical quantitative pharmacology strategy to support the immunology portfolio. * 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 mentorship to staff * Assists in recruitment and hiring **Knowledge and Skills:** * Strong foundational knowledge in the clinical pharmacology of biologics, small molecules, and/or other drug modalities * Working experience of Immunology and Autoimmune diseases therapeutic area or relevant disease knowledge * Experience in executing quantitative clinical pharmacology to derive decisions. Hands-on expertise in data analysis using industry-standard tools such as Phoenix WinNonlin, R, and NONMEM. * Experience of interaction with healthy authorities * Effective leadership skills to drive performance and provide career development opportunities to staff * Critical thinking skills, with keen scientific and deve

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