Senior Scientific Director - Biotherapeutics & Cell Therapy
Bristol Myers Squibb
5 months ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Position Responsibilities:
- Provide strategic leadership and accountability for bioanalytical PK and immunogenicity strategies across nonclinical and clinical development programs supporting biotherapeutics and cell therapies.
- Serve as the bioanalytical scientific lead on Project Teams, contributing to program strategy, risk assessment, and key decision making.
- Oversee the design, development, validation, and lifecycle management of bioanalytical assays, ensuring methods are fit-for-purpose and aligned with program and regulatory requirements.
- Partner cross-functionally with internal Bioanalysis Lab Scientists, Clinical Pharmacology, DMPK, Nonclinical, Clinical, and Regulatory teams to deliver integrated PK, exposure, biomarker, and PD strategies.
- Drive innovation through evaluation and implementation of emerging bioanalytical technologies to improve operational efficiencies and enable risk-based decision-making.
- Provide strategic oversight and hands-on leadership for regulatory submissions (IND, NDA/BLA, IB, CTA, and related documents), including authoring/reviewing bioanalytical and biomarker sections, ensuring scientific rigor/consistency/regulatory alignment, and leading responses to health authority questions.
- Oversee external bioanalytical CRO partners to ensure scientific quality, GLP/GCP adherence, and alignment with program timelines.
- Lead, mentor, and develop scientific talent; build high-performing teams.
- Travel as required to CRO sites for scientific and technical oversight.
Basic Qualifications:
- Bachelor’s Degree with 15+ years of academic and/or industry experience.
- OR Master’s Degree with 12+ years of academic and/or industry experience.
- OR Ph.D. (or equivalent advanced degree in the Life Sciences) with 10+ years of academic/industry experience and 8+ years of leadership experience.
Preferred Qualifications:
- Success leading bioanalytical strategy for IND-enabling and clinical-stage programs.
- Deep expertise in ligand binding assays, PK and immunogenicity bioanalysis, and method validation.
- Strong knowledge of global regulatory guidance (FDA, EMA) and GLP/GCP bioanalytical requirements.
- Proven ability to lead scientific teams and manage CROs in regulated environments.
- Excellent communication skills authoring high-quality regulatory/scientific documents.
- Track record of scientific leadership and influence across complex, matrixed organizations.
Benefits (explicitly listed):
- Health Coverage (medical, pharmacy, dental, vision), Wellbeing support programs, and Financial well-being/protection (401(k), disability, life insurance, etc.).
- Paid Time Off (flexible time off/paid holidays or paid vacation depending on location/role), plus additional eligibility-based time off options (e.g., sick time, volunteer days, leaves, Global Shutdown).
Compensation (explicitly listed):
- Princeton, NJ: US $250,800–$303,912 (starting range).
Application instructions:
- If a role doesn’t perfectly line up with your resume, BMS encourages applying anyway.
- Provide strategic leadership and accountability for bioanalytical PK and immunogenicity strategies across nonclinical and clinical development programs supporting biotherapeutics and cell therapies.
- Serve as the bioanalytical scientific lead on Project Teams, contributing to program strategy, risk assessment, and key decision making.
- Oversee the design, development, validation, and lifecycle management of bioanalytical assays, ensuring methods are fit-for-purpose and aligned with program and regulatory requirements.
- Partner cross-functionally with internal Bioanalysis Lab Scientists, Clinical Pharmacology, DMPK, Nonclinical, Clinical, and Regulatory teams to deliver integrated PK, exposure, biomarker, and PD strategies.
- Drive innovation through evaluation and implementation of emerging bioanalytical technologies to improve operational efficiencies and enable risk-based decision-making.
- Provide strategic oversight and hands-on leadership for regulatory submissions (IND, NDA/BLA, IB, CTA, and related documents), including authoring/reviewing bioanalytical and biomarker sections, ensuring scientific rigor/consistency/regulatory alignment, and leading responses to health authority questions.
- Oversee external bioanalytical CRO partners to ensure scientific quality, GLP/GCP adherence, and alignment with program timelines.
- Lead, mentor, and develop scientific talent; build high-performing teams.
- Travel as required to CRO sites for scientific and technical oversight.
Basic Qualifications:
- Bachelor’s Degree with 15+ years of academic and/or industry experience.
- OR Master’s Degree with 12+ years of academic and/or industry experience.
- OR Ph.D. (or equivalent advanced degree in the Life Sciences) with 10+ years of academic/industry experience and 8+ years of leadership experience.
Preferred Qualifications:
- Success leading bioanalytical strategy for IND-enabling and clinical-stage programs.
- Deep expertise in ligand binding assays, PK and immunogenicity bioanalysis, and method validation.
- Strong knowledge of global regulatory guidance (FDA, EMA) and GLP/GCP bioanalytical requirements.
- Proven ability to lead scientific teams and manage CROs in regulated environments.
- Excellent communication skills authoring high-quality regulatory/scientific documents.
- Track record of scientific leadership and influence across complex, matrixed organizations.
Benefits (explicitly listed):
- Health Coverage (medical, pharmacy, dental, vision), Wellbeing support programs, and Financial well-being/protection (401(k), disability, life insurance, etc.).
- Paid Time Off (flexible time off/paid holidays or paid vacation depending on location/role), plus additional eligibility-based time off options (e.g., sick time, volunteer days, leaves, Global Shutdown).
Compensation (explicitly listed):
- Princeton, NJ: US $250,800–$303,912 (starting range).
Application instructions:
- If a role doesn’t perfectly line up with your resume, BMS encourages applying anyway.