Principal Scientist, Drug Metabolism and Pharmacokinetics (REMOTE)

MSD

81d • $169,700 - $267,200

About The Position

The (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. Please note that standard commute is (less than) <50 miles. The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a dynamic and collaborative scientist for the Drug Metabolism and Pharmacokinetics (DMPK) group. The Principal Scientist will be a key contributor to multi-disciplinary drug development and discovery efforts providing an integrated understanding of DMPK properties, pharmacokinetics/pharmacodynamics (PK/PD), and drug interaction (DDI) risk of novel therapeutics. The key responsibilities will be to work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities. The Principal Scientist will guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile. They will assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models and guide clinical development teams on DDI strategy. They will author source reports and documents in support of regulatory filings. They will independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure efficient program progression and decision making. The ideal candidate must be able to work collaboratively in a fast-paced environment, drive scientific development and innovation, and have excellent interpersonal and communication skills. Experience supporting both small molecule and biologics programs is desired.

Requirements

• PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Pharmacodynamics, Chemistry, Biomedical Engineering, Biochemistry, Toxicology, Biology, or relevant STEM fields.
• Master’s degree with 10+ years relevant experience or PhD with 7+ years of industry/applied drug discovery/development experience in a relevant field.
• Experience in integrating preclinical DMPK and pharmacology to enable translational modeling and simulation to support dose selection.
• Experience in assessing the impact of various factors on the pharmacokinetics and pharmacodynamics of novel therapeutics.
• Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries.
• Demonstrated track record as an effective collaborator on multi-disciplinary discovery and development teams.
• Strong leadership, interpersonal, communication, problem solving, and collaboration skills.

Nice To Haves

• Strong publication track record.
• Experience representing the DMPK function in the evaluation of third-party assets.
• Experience building models and performing analyses using Phoenix and PBPK modeling software (e.g., SimCYP).
• Experience mentoring or supervising junior staff.

Responsibilities

• Work within teams of highly collaborative, cross-functional scientists to contribute to the discovery and clinical development of therapeutics across various modalities.
• Guide the design and interpretation of in silico, in vitro, and in vivo analyses to support the discovery of therapeutics with the desired DMPK profile.
• Assess DDI risk using static mechanistic and/or physiologically based pharmacokinetic (PBPK) models.
• Guide clinical development teams on DDI strategy.
• Author source reports and documents in support of regulatory filings.
• Independently evaluate and predict potential program risks.
• Implement appropriate strategies to address liabilities to ensure efficient program progression and decision making.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees