Sunovion Director, Drug Metabolism and Pharmacokinetics in Marlborough, Massachusetts

Job Description:

Actively participate on drug development teams, including non-clinical ADME and Clinical Pharmacology program and study designs, dosage selection study initiation and monitoring, report review and finalization, risk assessments, and regulatory interactions. Also, responsible for literature reviews, critical evaluations of in-licensing opportunities, and data summaries and presentations. As all studies are conducted externally, a fair amount of traveling (e.g. 15-20%) may be common, depending upon project assignments. Supervise, lead and support scientific and technical department of critical team contributors, including guidance and supervision of project specific strategies as well as day to day activities. Independent thinker with current scientific and technical skills, mature team practices and demonstrated supervisory/leadership effectiveness essential.

Job ID: 6570BR

Department: Research & Development

Location: Marlborough, MA

Job Type: Full-time

Summary of Responsibilities: Actively participate on drug development teams, including non-clinical ADME and Clinical Pharmacology program and study designs, dosage selection study initiation and monitoring, report review and finalization, risk assessments, and regulatory interactions. Also, responsible for literature reviews, critical evaluations of in-licensing opportunities, and data summaries and presentations. As all studies are conducted externally, a fair amount of traveling (e.g. 15-20%) may be common, depending upon project assignments. Supervise, lead and support scientific and technical department of critical team contributors, including guidance and supervision of project specific strategies as well as day to day activities. Independent thinker with current scientific and technical skills, mature team practices and demonstrated supervisory/leadership effectiveness essential.

Essential Functions: •Determine ADME studies needed to support discovery and development projects. Analyze and interpret data; communicate key results, especially as they impact project objectives.

•Maintain and grow high level scientific skills, including but not limited to PK/ADME, Physiological-Based PK modeling, Clinical Pharmacology, and other related areas of science. Serve as internal consultant and coach to expand and apply these skills internally.

•Lead by example and set clear direction for staff and peers. Supervise and support departmental staff, and participate directly in: initiation of studies at approved contract facilities following appropriate processes for protocol development, contract implementation.

•Clarify timeline commitments; assuring appropriateness of bio-analytical methods; selection of CROs, monitoring studies for accuracy and timely completion.

•Prepare and/or review draft reports for completion and consensus of opinions; evaluation of plasma and tissue exposure data, with preparation of verbal and written summaries of key results for internal discussions and for regulatory submissions.

•Coordinate tasks and across departments and CROs for efficiencies and synchronization to support team objectives. This includes effective communication as needed with colleagues in DSP.

•Anticipate problems and opportunities and raise issues and suggested resolutions to supervisor or appropriate team leader.

•Internal staff as well as external staff at multiple contract facilities must be effectively communicated with and managed in order to ensure the quality and timing requirements of the internal project teams.

•Contributions to, and cross-functional review of, various regulatory documents requires careful time management, mature communication and diplomacy skills, and attention to continuing improvements in existing processes.

•Participation in budget planning and management; lead and support negotiation efforts with CROs.

Minimum Education Requirements: Masters

Experience Required: 10+ Years

Knowledge & Skills (General and Technical): Education level and/or relevant experience(s):

•Ph.D. or equivalent in Medicinal Chemistry, Toxicology, Clinical Pharmacology or related health science field.

•Candidates with M.S. degree will be considered if supported by several additional years of demonstrated relevant experiences.

Knowledge and skills (general and technical):

•At least 10 years combined experience in the areas of bioanalytical chemistry, drug metabolism, pharmacokinetics and physiological-based PK modeling required.

•Balance of knowledge across these disciplines, including conducting and monitoring externally contracted ADME and bioanalytical studies, is essential.

•Proven ability to supervise senior staff and lead a growing department preferred. Working knowledge of GLP regulations, ICH guidance documents and experience conducting and monitoring ADME studies essential.

•Experience supporting drug development teams and preparing FDA submissions required. Working knowledge of toxicology and/or pharmacology is a plus.

•Extensive interactions across departments and external study monitoring responsibilities required solid time management and diplomacy skills.

•The candidate must demonstrated proficiency at working independently as well as in team settings, and able to build consensus with others. Occasionally, assignments will have relatively short deadlines and require expedited commitments with minimal disruptions to the remaining workflow; time management, task management and mature communication and team skills are essential.

Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): -Strong oral and written communication skills and demonstrated proficiency at technical presentations are essential.

-The individual must be highly self-motivated and an effective problem solver.

-Fast paced office environment handling multiple simultaneous demands. Must be able to exercise appropriate judgment as necessary.

-Requires a high level of initiation and independence. Requires ability to use a personal computer for extended periods of time.

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.