Associate Principal Scientist, Pharmacokinetics - West Point, United States - Merck Sharp & Dohme

Merck Sharp & Dohme

Verified Company

West Point, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 Associate 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 Associate 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 evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities to ensure efficient program progression and decision making.

Qualifications

Education Minimum Requirement:

B.S., Master's degree, or Ph.

D. in Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Biochemistry, or relevant fields.

Required Experience and Skills:

B.S. with 12+ years relevant experience, Master's degree with 8+ years relevant experience, or Ph.

with 4+ years of industry experience in a relevant field with a focus on discovery and development of therapeutics of various modalities.

Experienced in integrating preclinical DMPK and pharmacology to enable translational modeling and simulation to support dose selection, design of PK/PD and safety assessment studies, and dose justifications for preclinical and clinical studies.
Experience in assessing the impact of various factors on the pharmacokinetics and pharmacodynamics of novel therapeutics and communicating analyses and recommendations to interdisciplinary teams and management.
Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries.
Demonstrated track record as an effective collaborator on multidisciplinary discovery and development teams.
Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines.

Preferred Experience and Skills:

Strong publication track record
Experience building models and performing analyses using Phoenix and PBPK modeling software (e.g., SimCYP).
Experience mentoring or supervising junior staff.
Experience with biologics

NOTICE FOR INTERNAL APPLICANTS

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.

To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

US and Puerto Rico Residents Only:
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.

All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

For more information about personal rights under the U.S. Equal Opportunity Employment l