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    Sr. Manager, Pharmacokinetics (Pk) Modeler Sr. Manager, Pharmacokinetics (Pk) Modeler

    Sun Pharma
    5+ years
    Not Disclosed
    Princeton Junction
    10 Jan. 5, 2025
    Job Description
    Job Type: Full Time Education: PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Sr. Manager, Pharmacokinetics (PK) Modeler
    Date: December 20, 2024
    Location: Princeton, NJ (Hybrid)
    Company: Sun Pharmaceutical Industries, Inc.

    Sun Pharma, the world’s fourth-largest generics company, delivers high-quality medicines in Specialty, Generics, and Consumer Healthcare products to over 100 countries. With a robust presence supported by 40+ manufacturing facilities worldwide, Sun Pharma has established itself as a leader in the U.S. generics market and is rapidly expanding into specialty branded markets focusing on dermatology, ophthalmology, and onco-dermatology.

    This role is based in Princeton, NJ, with a hybrid work schedule: three days in-office and two days remote.

    Position Summary

    Sun Pharma seeks a Senior Manager, Pharmacokinetics (PK) Modeler to join its Quantitative Pharmacology group within the Translational Medicine and Clinical Pharmacology function. This team oversees clinical pharmacology and pharmacometric strategies for clinical development candidates, collaborating closely with nonclinical and clinical teams across therapeutic areas.

    The ideal candidate will bring expertise in quantitative drug development, a strong background in pharmacometrics, and the ability to work across functional areas and with external partners. This position offers a collaborative environment emphasizing teamwork, creativity, and professional growth.

    Key Responsibilities

    Strategic Development Contributions

    • Serve as a key member of product development teams, integrating quantitative insights into strategic decisions for novel chemical entities.
    • Develop and implement Model-Informed Drug Development (MIDD) plans, leveraging techniques such as population PK/PD, exposure-response modeling, disease progression modeling, and quantitative systems pharmacology (QSP).
    • Support global marketing application filings, including preparation of regulatory documents and presentations.
    • Evaluate internal and external opportunities, contributing to strategic assessments.

    Pharmacometric Expertise

    • Conduct advanced quantitative analyses, including population PK models, PBPK models, and advanced mechanistic PK/PD models.
    • Apply FDA, EMA, and ICH guidelines in designing MIDD strategies and preparing regulatory submissions.
    • Mentor and guide junior staff in pharmacometric methods and career development.

    Cross-Functional Collaboration

    • Interface with key functions, including discovery sciences, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research.
    • Communicate results and interpretations clearly and effectively to functional teams and senior management.

    Operational Excellence

    • Ensure timely and high-quality execution of quantitative analyses to support clinical development programs.
    • Drive implementation of pharmacometric principles and best practices across therapeutic areas.
    • Foster a collaborative and fast-paced environment conducive to innovation and continuous improvement.

    Qualifications

    Education

    • PhD in a quantitative science (e.g., statistics, mathematics, engineering, physics, computer science) or PharmD.

    Experience

    • Minimum 5+ years of postdoctoral experience in pharmacometrics or quantitative pharmacology within the biotech/pharmaceutical industry.
    • Proven experience in developing and applying quantitative methods in drug development.
    • Strong hands-on modeling and simulation expertise using NONMEM, R, and related tools.

    Skills

    • In-depth knowledge of population PK models, PBPK models, disease progression models, and mechanistic PK/PD modeling.
    • Strong track record of scientific scholarship and collaboration across therapeutic areas.
    • Excellent interpersonal, writing, and presentation skills, with the ability to function effectively in a team environment.

    Compensation & Benefits

    This position offers:

    • Participation in the Annual Performance Bonus Plan.
    • Comprehensive benefits, including medical, dental, and vision coverage.
    • Life and disability insurance.
    • 401(k) savings plan with employer match.
    • Flexible spending accounts and employee assistance program.
    • Paid time off, including vacation and sick leave.

    Equal Opportunity Employment

    Sun Pharma is committed to providing equal employment opportunities, ensuring non-discrimination based on race, religion, color, national origin, sex, age, disability, sexual orientation, veteran status, or other protected categories.

    Agency Notice

    Sun Pharma does not accept unsolicited resumes from agencies or search firms. Submissions without a signed agreement will become the property of Sun Pharma, and no fee will be paid for such referrals.

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