Vertex
Biotechnology
ClinicalPharmacologyDirector
Neural analysis suggests this role is
optimal for Director candidates.
“Clinical Pharmacology Director at Vertex. Skills: Clinical Pharmacology, Quantitative pharmacology, Drug development. Lead strategic aspects. Lead scientific aspects”
Industry & Context.
Critical thinking; Scientific judgment; Development judgment
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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