Jobs · New Jersey

Senior Director, Data Science

TalentAlly · Rahway, NJ · 3 wk ago
HybridFull-time

Our Company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are recognized as an industry leader in immuno-oncology (IO) and vaccines discovery and development. For more than a century, our Company has translated scientific innovation into medicines and vaccines that improve and save lives worldwide—anchored in ethical integrity, scientific excellence, and a clear mission to transform global health.

About the role

We are seeking an accomplished scientific leader to join the Quantitative Pharmacology and Pharmacometrics - Oncology (QP2 Oncology) team as Senior Director, Group Leader. This role provides strategic leadership and scientific oversight across a significant portion of the oncology portfolio, focusing on clinical pharmacology, mechanistic PK-PD modeling, and pharmacometrics for oncology programs from post-preclinical candidate (PCC) selection through registration.

The Senior Director, Group Leader will lead a team of QP2 scientists and serve as a key contributor to oncology program strategy by applying model-informed drug development (MIDD) approaches to support critical decisions. Reporting directly to the QP2 Oncology Executive Director, the individual will collaborate closely with cross-functional partners, including Clinical Development, Translational Medicine, Biostatistics, and Regulatory, as well as preclinical partners to inform first-in-human and clinical development strategies.

Responsibilities

  • Strategic & Scientific Leadership
    • Lead and shape quantitative pharmacology strategy across oncology programs to inform key development decisions (e.g., dose selection, trial design, go/no-go decisions).
    • Develop and implement integrated MIDD strategies to support decision-making across development stages.
    • Ensure alignment of modeling strategies with regulatory expectations and business priorities.
    • Maintain a comprehensive understanding of global regulatory expectations for small molecules, biologics including new modalities such as ADCs and TCEs.
  • Team Leadership & Organizational Impact
    • Lead, mentor, and develop a team of QP2 scientists, including performance management, hiring, retention, and talent development.
    • Provide scientific and operational oversight to team members, ensuring high-quality and timely deliverables.
    • Contribute to broader QP2 and Oncology leadership initiatives, including talent strategies and organizational priorities.
    • Identify and support resource planning and allocation in partnership with senior leadership.
  • Program & Cross-Functional Leadership
    • Serve as QP2 lead on assigned programs and represent QP2 in cross-functional teams and governance forums.
    • Collaborate with Translational, Clinical, and Biostatistics teams to integrate quantitative insights into development strategies.
    • Partner with preclinical teams to ensure appropriate translation of nonclinical findings into clinical development plans.
    • Contribute to due diligence for business development and licensing opportunities.
  • Regulatory & External Engagement
    • Develop and contribute to regulatory strategies, including authoring and reviewing key documents (e.g., INDs, CSRs, CTD modules, NDA/BLA submissions).
    • Ensure delivery of high-quality clinical pharmacology and pharmacometric analyses and reports.
    • Represent the company in interactions with regulatory agencies, scientific conferences, and external collaborations.

Requirements

  • Ph.D. in pharmacokinetics/pharmacodynamics, pharmacometrics, mathematics, statistics/biostatistics, chemical/biomedical engineering, or related discipline with 10 years of relevant pharmaceutical industry experience, or Master's, PharmD, or equivalent degree with 15 years of relevant pharmaceutical industry experience, with a demonstrated record of increasing responsibility, independence, and leadership in similar roles.
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, computational biology, or a related field.
  • Oncology therapeutic area or disease knowledge.
  • Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others.
  • Extensive experience in developing quantitative strategies for impacting pipeline decisions and drug development expertise.
  • Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA).
  • Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity.
  • Relevant regulatory and quantitative pharmacology experience.
  • Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Skills

  • Required Skills: Biopharmaceutical Industry, Biopharmaceutics, Business Intelligence (BI), Computational Biology, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Drug Development, Due Diligence, Immunoassays, Immunotherapy, Machine Learning (ML), Pharmacodynamics, Pharmacokinetics, Pharmacotherapeutics, Product Approvals, Software Development, Stakeholder Relationship Management, Waterfall Model.
  • Preferred Skills: (Not specified beyond required skills).

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