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Clinical Pharmacology Director

Vertex Pharmaceuticals

Job DescriptionGeneral 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 initiativesCreates protocol concepts and guides protocol start-up including site initiations and investigator meetingsOversees and contributes to regulatory and safety documentsContributes to clinical pharmacology summary documentsGuides PK analysesPerforms PK/PD or exploratory analyses and guides PK/PD modeling or simulations as appropriateProvides mentorship to staffAssists in recruitment and hiringKnowledge and Skills:Strong foundational knowledge in the clinical pharmacology of biologics, small molecules, and/or other drug modalitiesWorking experience of Immunology and Autoimmune diseases therapeutic area or relevant disease knowledgeExperience 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 authoritiesEffective leadership skills to drive performance and provide career development opportunities to staffCritical thinking skills, with keen scientific and development judgmentExperience planning and executing Clinical Development Plans for new clinical entities particularly as it applies to the discipline of Clinical PharmacologyExperience conducting and supervising clinical studies such as drug-drug interaction, special population or bioavailabilityExperience with a range of clinical studies including first-in-human, proof-of-concept and registrational studiesExperience contributing to clinical and regulatory documents such as the Investigator’s Brochure and contributing to regulatory correspondenceExperience working on teams and in a matrix environmentEducation 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, orMasters Degree (or equivalent degree) in pharmacokinetics, pharmacometrics, clinical pharmacology or translational development and 15+ years of relevant employment experienceTypically requires 3 years of supervisory/management experience#LI-KM4Pay Range:$200,000 - $300,000Disclosure 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 Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io: Boston, MAType: Full time

Vacancy posted 2 days ago
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