Sunovion Director, Clinical Pharmacology in Marlborough, Massachusetts
Provide leadership and serve as internal expert in clinical pharmacology and pharmacometrics and their applications to Sunovion research and development programs. Lead the strategic and operational planning of clinical pharmacology studies, including but not limited to: identify key program objectives, design and creation of clinical protocols, resource planning (budgets, timelines, and personnel requirements), applications of modeling and simulation, interpretation and communication of results. Provide clinical pharmacology support for post-approval commitments, life cycle management, global standards (EMA, PMDA), due diligence activities, and other opportunities to support Sunovion programs.
Job ID: 6569BR
Department: Research & Development
Location: Marlborough, MA
Job Type: Full-time
Summary of Responsibilities: Provide leadership and serve as internal expert in clinical pharmacology and pharmacometrics and their applications to Sunovion research and development programs. Lead the strategic and operational planning of clinical pharmacology studies, including but not limited to: identify key program objectives, design and creation of clinical protocols, resource planning (budgets, timelines, and personnel requirements), applications of modeling and simulation, interpretation and communication of results. Provide clinical pharmacology support for post-approval commitments, life cycle management, global standards (EMA, PMDA), due diligence activities, and other opportunities to support Sunovion programs.
Essential Functions: •The Director of Clinical Pharmacology is accountable for planning and integrating clinical pharmacology studies, which meet standards of excellence, ethical, regulatory, and legal requirements, into overall clinical development program objectives. The Director ensures that clinical pharmacology studies meet agreed timelines and budget and deliver pivotal, decision-making knowledge for the programs.
•Contributes to functional excellence in science, including population modeling and simulation applications in drug development and regulatory science. Maintains contact and establishes strong reputation with the external scientific community through publications and other initiatives.
•Defines resourcing and outsourcing strategy for the operational aspects of clinical pharmacology and external collaborations in modeling and simulation. Directly oversees critical path activities with external artners.
•Manages Associates/Assistants, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
•Serves as internal consultant for all development teams.
•Defines future directions for Translational Medicine, especially in areas related to novel methodology in clinical science and pharmacometrics.
Minimum Education Requirements: Masters
Experience Required: 10+ Years
Knowledge & Skills (General and Technical): Education level and/or relevant experience(s):
•A Ph.D. degree in pharmaceutics or Pharm D is preferred.
•10-15 years+ experience in drug development science, including drug metabolism, PK, PK/PD, biomarkers, writing and regulatory interactions.
Knowledge and skills (general and technical):
•Clinical Pharmacology Study Planning - Thorough understanding and experience in the planning and execution of phase 1 volunteer studies (i.e., clinical trial management of phase 1 studies); Experience with multiple phase 1 units that concentrate in; special populations (elderly, pediatric) RI-AME, First in Man, Impairment, PET/EEG and DDI; Knowledge of clinical pharmacology study requirements including protocol input, CSR’s, and other program documents.
•Cutting-edge knowledge of pharmacometric science and regulatory applications of modeling a simulation in drug development.
•Excellent communication and negotiation skills; Ability to function in a cross-cultural environment.
•Exceptional interpersonal skills (globally, internally and externally).
•Line management experience, and proven ability to lead and manage a team; Excellent planning and organizational skills.
•High level of initiative and ability to work independently under minimal supervision.
•Proven ability to support innovation even if taken outside of his/her comfort zone; Demonstrated pragmatism and willingness to drive and support change; Demonstrated ability to challenge established practices and concepts.
Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): -Proficient in MS suite (Word, Excel, and Projects) and Adobe Acrobat.
-Proficient in at least one modeling and simulation computational environment, e.g. NONMEM, WNL Phoenix, Monolix, etc.
-10-20% travel (domestic or international).
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.