Senior Director, Clinical Science, Genitourinary (GU) Oncology (Hybrid)
About The Position
The Senior Director, Clinical Science, Genitourinary (GU) Oncology provides strategic Clinical Science leadership across multiple studies, programs, and assets. Reporting to the Executive Director, the role contributes to disease area strategy and development planning, applying deep expertise in GU cancers to guide scientific approaches and promote consistent standards, medical data review practices, and decision-making across the portfolio. The Senior Director partners with Section Heads, Asset Leads, Program Development Team Leads, and cross-functional colleagues on study planning, data interpretation, issue resolution, and program decisions. The role shapes Clinical Science practices across the GU cancers portfolio through standardization, integration of insights across assets, and promotion of innovative tools such as visual analytics, centralized data review, and AI-enabled workflows. It may include direct management and development of multiple Clinical Scientists. The position collaborates closely with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, Medical Affairs, and other partner functions. It contributes to governance discussions and senior leadership reviews, supports compliance and inspection readiness, and advances the quality and effectiveness of Clinical Science work. The role is hybrid, based primarily in Rahway, New Jersey, with 10% travel required.
Requirements
- Advanced scientific or healthcare degree (for example, PhD or PharmD) or equivalent, with 8 or more years of pharmaceutical, clinical drug development, and/or medical field experience; OR a master's degree, preferably in life sciences, with 12 or more years of such experience; OR a bachelor's degree, preferably in life sciences, with 15 or more years of such experience.
- Significant experience in Clinical Development, Clinical Science, clinical drug development, or a related function in the pharmaceutical or biotechnology industry.
- Demonstrated Clinical Science leadership across multiple studies, programs, or assets.
- Deep therapeutic expertise, including understanding of disease biology, current and emerging treatment landscapes, clinically relevant endpoints, and scientific considerations affecting development.
- Strong understanding of clinical trial design, clinical development strategy, clinical data review, and oncology data interpretation.
- Experience contributing to disease area strategy, portfolio discussions, or cross-program planning.
- Experience contributing to regulatory submissions, safety reviews, or health authority interactions.
- Experience working effectively in cross-functional teams in a matrix environment.
- Ability to integrate information across studies and programs to support scientific and business decisions.
- Excellent communication, influence, and executive presentation skills.
- Demonstrated people leadership experience, including managing, coaching, and developing scientific staff.
- Required skills listed: Clinical Development, Clinical Research, Clinical Research Management, Clinical Sciences, Clinical Trial Planning, Oncology, People Leadership, Study Design, Therapeutic Knowledge, and Trial Design.
Nice To Haves
- Preferred skills listed: Leadership, Oncology Trials, and People Management.
Responsibilities
- Provide strategic Clinical Science leadership across multiple studies, programs, and assets in the disease area.
- Contribute Clinical Science input to disease area strategy, development opportunities, portfolio risks, and interpretation of emerging data.
- Partner with Section Heads, Asset Leads, Program Development Team Leads, and cross-functional leaders to align Clinical Science activities with program and disease area objectives.
- Apply expertise in GU cancer biology, treatment landscapes, and clinically meaningful endpoints to study planning, data interpretation, and issue resolution.
- Integrate scientific insights across studies and assets to inform development decisions.
- Standardize Clinical Science approaches, medical data review practices, data interpretation principles, deliverables, and portfolio practices.
- Promote consistent scientific approaches across assets, including consideration of endpoints, patient populations, safety topics, and emerging scientific issues.
- Advocate for visual analytics, centralized data review, AI-enabled workflows, and other improvements to quality and efficiency.
- Guide interpretation of clinical data across studies, cohorts, and assets and identify issues for cross-functional and governance discussions.
- Contribute scientific perspective to protocols, amendments, study design, endpoint selection, eligibility criteria, biomarker strategy, and development planning.
- Serve as a Clinical Science subject matter resource for the disease area across study teams and partner functions.
- Contribute to portfolio discussions, governance reviews, senior leadership meetings, program reviews, and management communications.
- Present cross-study insights, scientific assessments, and key issues to cross-functional leaders and governance bodies.
- Translate portfolio priorities into Clinical Science strategies, capabilities, and resource plans.
- Manage, coach, mentor, and develop Directors, Principal Scientists, and Clinical Scientists, as appropriate.
- Set expectations for scientific quality, strategic thinking, collaboration, communication, and consistent ways of working.
- Foster accountability, inclusion, continuous learning, and strong team performance.
- Represent Clinical Science in cross-functional planning, program discussions, and strategic decision-making forums.
- Ensure Clinical Science activities follow applicable regulatory requirements, company policies, and established procedures.
- Support inspection readiness and appropriate documentation of Clinical Science contributions.
- Identify opportunities to improve Clinical Science quality, consistency, and effectiveness, and maintain awareness of relevant scientific, clinical, and regulatory developments.
Benefits
- Medical, dental, vision, healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including a 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
