Req ID 4103BR Department Clinical Pharmacology Location Cambridge, MA Job Description
Vertex Pharmaceuticals, Inc. is looking for an Associate Director to join the Clinical Pharmacology team here at Vertex.
The Associate Director’s (AD) responsibilities include assisting the planning and execution of the Clinical Development Plan for new clinical entities particularly as it applies to the discipline of Clinical Pharmacology. The AD will supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability, working with Vertex teams. The AD will supervise or conduct non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses. The AD will provide support for other studies such as first-in-human, proof-of-concept or registrational studies. The AD will provide key guidance on clinical and regulatory documents such as the Investigator’s Brochure and will contribute to regulatory correspondence. The AD will represent Clinical Pharmacology on cross-functional teams and within Vertex governance to provide procedural and strategic guidance. The AD will possess key leadership skills which drive performance and create enthusiasm. The AD will be able to understand cross-functional needs, develop critical rationale, communicate clearly, collaborate with peers and drive innovation. Working within the Translational Medical Sciences Division, the AD will ensure close collaboration of Clinical Pharmacology with Modeling and Simulation and Biomarkers.
- Responsible for operational leadership within the clinical pharmacology department and within the company’s matrix for drug development
- Oversees or conducts the design, conduct, analysis and interpretation of clinical pharmacology and biopharmaceutic studies from phase 1-4 development, including management of outsourced activities
- Supports other clinical studies including First-in-Human, Proof-of-Concept and Pivotal studies
- Contributes to clinical study reports, regulatory correspondence, safety documents and other internal and external reports and presentations
- Helps define scientific and strategic direction, working within the matrix structure
- Provides operational leadership to development teams
- Effectively interacts with peers, subordinates and senior management to move projects forward
- Helps direct effective, timely and ethical publication and patenting activities for the group
- Effectively acts on company objectives and lives the Vertex Values
- Supervises other Clinical Pharmacology staff, with all incumbent managerial responsibilities including career development
- Able to integrate the activities of distinct functional groups across multiple projects
- Displays critical thinking and problem-solving abilities Minimum Qualifications
- PharmD, Ph.D., PharmD/PhD or MD/PhD and 5+ years of industry or regulatory agency experience
- NCE drug development experience with at least 5 NCEs in the past
VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law.
- Formal non-compartmental pharmacokinetic training
- At least 1 year of academic fellowship or post-doctoral experience including publications in peer-reviewed
- Possesses good knowledge of drug Development Programs and a keen awareness of development issues
- Is a mid-level experienced mentor
- Can make clear written and oral presentations. Company Information Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, and most recently was named the top employer in Science magazine's 2011 annual survey. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex Pharmaceuticals aims to cure patients with previously incurable diseases. The biotechnology company uses an integrated,...