Sunovion Associate Director/Director, Drug Metabolism and Pharmacokinetics (DMPK) in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for an Associate Director/Director, Drug Metabolism and Pharmacokinetics (DMPK) to join our Clinical Pharmacology Team.
The primary objectives of this position are to actively participate on drug development teams, including non-clinical absorption, distribution, metabolism, and excretion (ADME) and Clinical Pharmacology study designs and monitoring, data interpretation, report review and finalization, and regulatory interactions. Expertise in physiological-based PK (PBPK) modeling and simulation is desirable. The candidate will also be responsible for literature reviews and presentations. We seek an independent thinker with current scientific and technical
skills, productive team practices and demonstrated leadership effectiveness.
Determine what ADME studies are needed and when to support discovery and development projects. Analyze and interpret data; communicate key results.
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.
Initiation of studies at approved contract facilities, including protocol development.
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.
Anticipate problems and opportunities and raise issues and suggest solutions with supervisor or appropriate team leader.
Contributions to, and cross-functional review of, various regulatory documents require time management, 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, Experience, Knowledge and Skills Required:
M.S. or higher in Medicinal Chemistry, Toxicology, Clinical Pharmacology or related health science field.
At least 10-15 years combined experience in the areas of drug metabolism, clinical pharmacology, pharmacokinetics, or physiological-based PK modeling required.
Operational experience with PBPK software and applications of such.
Operational experience with WinNonlin and applications of such.
Balance of knowledge across these disciplines, including conducting and monitoring externally contracted ADME studies, is essential.
Strong oral and written communication skills and demonstrated proficiency at technical presentations are essential.
Working knowledge of GLP regulations, ICH guidance documents essential.
Working knowledge of toxicology and/or pharmacology is a plus.
The individual must be highly self-motivated and an effective problem solver.
The candidate must work independently as well as in team settings and be able to build consensus with others.
Fast paced office environment handling multiple simultaneous demands.
Health and Safety: To maintain the health and safety of our employees, patients, and affiliates, as well as comply with the vaccination requirements of our partners, employees are required to be vaccinated against COVID -19. Candidates hired must provide proof of vaccination against COVID-19 within 5 days post hire as a condition of employment. In accordance with Equal Employment Opportunity laws, exemptions for religious and medical reasons will be considered.
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 personal 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.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Lead the way to a healthier world by putting patients at the center of everything we do
We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.
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.
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