Director, Clinical Pharmacology at Vertex
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.
Vertex Pharmaceuticals Incorporated is looking for an innovative leader to join the Clinical Pharmacology team at Vertex. The Director manages strategic, scientific and operational aspects of programs from the clinical pharmacology perspective and represents Clinical Pharmacology on cross-functional teams and within Vertex governance to provide procedural and strategic guidance. The Director will possess key leadership skills which drive performance and create enthusiasm and will supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability, working with Vertex teams. The Director will provide support for other studies such as first-in-human, proof-of-concept or registrational studies. The Director will provide key guidance on clinical and regulatory documents such as the Investigator’s Brochure and will contribute to regulatory correspondence. The Director 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 Director will ensure close collaboration of Clinical Pharmacology with Modeling and Simulation and Biomarkers. The Director will routinely supervises associate program leads, co-lead cross-functional efforts and lead department initiatives.
- 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 biopharmaceutical 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
- Represents clinical pharmacology on strategic and operational cross-functional development teams
- Represents clinical pharmacology at regulatory meetings and provide input on regulatory documents and interactions
- Helps define scientific and strategic direction, working within the matrix structure
- 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
- PharmD, Ph.D., PharmD/PhD or 10+ years of industry or regulatory agency experience
- NCE drug development experience with at least 5 NCEs in the past
- Formal non-compartmental pharmacokinetic training
- At least 1 year of academic fellowship or post-doctoral experience including publications in peer-reviewed journals
- Possesses good knowledge of drug Development Programs and a keen awareness of development issues
- Strong people manager
- Effective communication skills, both verbal and written
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.