Principal Scientist, Pharmacokinetics

Merck; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Merck is seeking a Principal Scientist in the DMPK group at West Point, PA to lead integrated DMPK analyses across modalities, delivering PK/PD insights to support development and discovery of novel therapeutics. The role emphasizes cross-functional collaboration, in silico/in vitro/in vivo analyses, and DDI risk assessment to guide clinical programs.

The candidate will drive program decisions and mentor staff in a fast-paced environment.

Qualifications

• PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Chemistry, Biomedical Engineering, Biochemistry, or relevant life sciences fields.
• Demonstrated ability to support early to late stage clinical development programs as a DMPK representative including evaluating and mitigating risks, integrating emerging data into ongoing programs, and clearly communicating with a varied development team.
• Ability to drive DDI strategy for clinical programs, ensuring timely risk assessment and appropriate clinical plans are in place.
• Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries.
• Experience working as a DMPK lead on discovery teams advancing therapeutics to clinical development across modalities (small molecule, peptides, biologics and conjugates).
• Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines.

Responsibilities

• Work within cross-functional teams to contribute to clinical development and discovery of therapeutics across modalities.
• Guide design and interpretation of in silico, in vitro, and in vivo analyses to support DMPK
• Assess program risks including DDI, metabolism and translation to guide clinical development teams.
• Author source reports and regulatory documents in support of filings.
• Independently evaluate and predict potential program risks and implement strategies to address liabilities.

Skills

ADME

Bioanalytical Method Development

Biopharmaceuticals

Biopharmaceutics

Business Interactions

Clinical Development

Clinical Judgment

Cross-Functional Teamwork

Detail-Oriented

Drug Development

Drug Interactions

Drug Metabolism

Immunoassays

Innovation

Life Science

Mentoring Staff

Pharmacodynamics

Pharmacokinetics

Pharmacology

PKPD Modeling

Education

PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Chemistry, Biomedical Engineering, Biochemistry, or relevant life sciences fields.

Job description

Job 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 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.

Job 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 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 clinical development and discovery 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 development and discovery of therapeutics with the desired DMPK profile. They will assess program risks including DDI, metabolism and translation to guide clinical development teams. They will author source reports and regulatory documents in support of filings. They will independently evaluate and predict potential program risks, while implementing appropriate strategies to address liabilities and 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 (e.g. antibodies and drug conjugates) programs is desired.

Education Minimum Requirement

• PhD or Master’s degree in Pharmaceutical Sciences, Pharmacology, Chemistry, Biomedical Engineering, Biochemistry, or relevant life sciences fields.

Required Experience And Skills

• Master’s degree with 12+ years relevant experience or PhD with 8 + years of industry experience in a relevant field with a focus on discovery and development of therapeutics of various modalities (including small molecules, antibodies, and drug conjugates).
• Demonstrated ability to support early to late stage clinical development programs as a DMPK representative including evaluating and mitigating risks, integrating emerging data into ongoing programs, and clearly communicating with a varied development team.
• Ability to drive DDI strategy for clinical programs, ensuring timely risk assessment and appropriate clinical plans are in place.
• Experience with authoring documents in support of IB, IND, WMA filings, and responses to regulatory inquiries.
• Experience working as a DMPK lead on discovery teams advancing therapeutics to clinical development across modalities (small molecule, peptides, biologics and conjugates).
• Strong leadership, interpersonal, communication, problem solving, and collaboration skills, while delivering results on firm deadlines.

Preferred Experience And Skills

• 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.

Required Skills

ADME, Bioanalytical Method Development, Biopharmaceuticals, Biopharmaceutics, Business Interactions, Clinical Development, Clinical Judgment, Cross-Functional Teamwork, Detail-Oriented, Drug Development, Drug Interactions, Drug Metabolism, Immunoassays, Innovation, Life Science, Mentoring Staff, Pharmacodynamics, Pharmacokinetics, Pharmacology, PKPD Modeling

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

• EEOC Know Your Rights
• EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Salary Range

$173,200.00 - $272,600.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.