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    Director, Quantitative Pharmacology And Pharmacometrics – Immune/Oncology (Remote)

    Msd Inventing For Life
    7+ years
    $181,600 - $285,800 per year
    Remote, USA
    10 July 22, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position: Director, Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO)
    Location: Remote (with occasional on-site presence at primary U.S. facilities)
    Salary Range: $181,600 - $285,800 per year

    Role Overview:

    We are seeking an experienced and talented scientist to join our Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team as a Director. This role is integral to the Global Clinical Development organization, focusing on the clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. The Director will lead quantitative drug development efforts, collaborating with cross-functional teams to advance novel chemical entities. This position demands strong leadership, strategic insight, and exceptional communication skills.

    Key Responsibilities:

    • Expert Representation: Serve as the expert representative for the QP2-IO team on oncology development projects.
    • Strategic Modeling: Develop and execute model-based analyses, including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, and quantitative systems pharmacology (QSP) modeling.
    • Clinical Trial Design: Strategize and execute modeling for tumor size and survival endpoints, including proportional hazards models.
    • Regulatory Expertise: Maintain an understanding of global regulatory expectations for oncology drugs. Author regulatory documents (INDs, CSRs, CTDs) and represent QP2-IO at regulatory meetings.
    • Mentoring: Mentor and supervise junior staff, fostering their development and capabilities in pharmacometrics.
    • Collaboration: Work closely with cross-functional teams and external partners to ensure alignment and drive impact on drug development strategies.

    Required Qualifications:

    • Education: Ph.D. in Pharmacokinetics, Pharmacodynamics, Pharmacometric, Mathematics, Statistics/Biostatistics, or a related field, with at least four years of pharmaceutical drug development experience. Alternatively, a Master’s or PharmD with at least six years of experience in a similar role.
    • Experience: Proven experience with pharmacometrics methods and regulatory submissions (IND, NDA). Demonstrated impact in drug development through model-based approaches.
    • Skills: Expertise in experimental design, data analysis, statistical methods, and proficiency in R, NONMEM, or similar programming languages.
    • Communication: Strong verbal and written communication skills.
    • Leadership: A track record of increasing responsibility and independence, with demonstrated impact on drug development decisions.

    Additional Information:

    • Travel: Up to 10% travel may be required.
    • Hybrid Work Model: Effective September 5, 2023, employees will generally work three days on-site per week and one day remotely, unless the role is designated as fully remote.
    • Relocation and VISA: Domestic relocation is available, and VISA sponsorship is provided.
    • Benefits: Includes bonus eligibility, long-term incentives (if applicable), healthcare and insurance benefits, retirement benefits, paid holidays, vacation, and sick days.

    Equal Opportunity Employer:

    Our company is 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. For more information on personal rights under U.S. Equal Opportunity Employment laws, please visit the EEOC website.

    Internal Applicants: In accordance with the Managers' Policy on Job Posting and Employee Placement, employees must have a minimum of twelve (12) months in their current position before applying for open positions.

    Search Firm Representatives: Unsolicited resumes from search firms are not accepted. All CVs submitted without a valid written agreement will be considered the property of our company.

    Application Deadline: Please apply by 11:59:59 PM on the day before the job posting end date, September 27, 2024.

    For more information about this position and to apply, please visit our careers page.

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