Associate Principal Scientist, Pharmacokinetics, Dynamics, Metabolism
1 month ago
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 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.
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.
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.D. 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 multi-disciplinary 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
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
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:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/1/2024*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.
Job Posting End Date:06/01/2024
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.
Requisition ID:R295520
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