Senior Director, Clinical Science, Gastrointestinal (GI) Oncology (Hybrid)
Merck & Co.
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Zusammenfassung
Merck & Co. in Rahway, NJ, USA is seeking a Senior Director, Clinical Science, GI Oncology to lead strategic Clinical Science across the GI portfolio.
You will shape disease area strategies, promote standardization, and partner with Clinical Operations, Medical Affairs, and Regulatory colleagues to guide development decisions. This leadership role requires deep GI cancer expertise, senior scientific judgment, and proven ability to manage and mentor Clinical Scientists in a matrix environment.
Qualifikationen
- Advanced scientific or healthcare degree required (PhD/PharmD) with 8+ years in pharmaceutical, clinical drug development.
- Experience leading Clinical Science across multiple studies, programs, or assets.
- Deep therapeutic area expertise in Gastrointestinal (GI) cancers with strong understanding of disease biology and endpoints.
- Strong oncology trial design, data review, and interpretation skills in a regulatory environment.
- Experience working in cross-functional, matrix organizations with executive stakeholders.
Aufgaben
- Provide strategic Clinical Science leadership across the GI oncology portfolio, spanning studies and assets.
- Guide interpretation of clinical data across studies and assets to inform development decisions.
- Support protocol development, amendments, and study design considerations.
- Lead standardization of Clinical Science practices and governance across programs.
- Foster cross-functional collaboration and effective communication with senior leadership.
Kenntnisse
Ausbildung
Jobbeschreibung
The Senior Director, Clinical Science, Gastrointestinal (GI) Oncology is responsible for providing strategic Clinical Science leadership, with accountability spanning multiple studies, programs, and assets. Reporting to the Executive Director, this role contributes to disease area strategy by applying deep therapeutic expertise to guide Clinical Science approaches, support development planning, and promote consistency in scientific standards, medical data review practices, and decision-making across the portfolio. The individual in this role is expected to bring deep knowledge of Gastrointestinal (GI) Cancers, including disease biology, current and emerging treatment landscape, relevant clinical endpoints, and key scientific considerations that influence development strategy and study design. The Senior Director partners closely with Section Heads, Asset Leads, Program Development Team Leads, and cross-functional development team members to support study planning, data interpretation, issue resolution, and broader program decisions across assigned studies and programs. This role has a strong strategic orientation and is expected to shape how Clinical Science work is performed across the Gastrointestinal (GI) Cancers portfolio, including standardization of practices, alignment of scientific approaches, and integration of insights across assets. The Senior Director may have responsibility for direct management and development of multiple Clinical Scientists and is expected to provide leadership, coaching, and clear direction within a matrix environment. The role requires close collaboration with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, Medical Affairs, and other key partner functions, as well as contribution to governance discussions and senior leadership reviews.
- Provide strategic Clinical Science leadership across the disease area, including multiple studies, programs, and assets.
- Contribute to disease area strategy by providing Clinical Science input on development opportunities, scientific considerations, portfolio risks, and implications of emerging internal and external data.
- Partner with Section Heads, Asset Leads, Program Development Team Leads, and cross-functional leaders to support alignment of Clinical Science activities with broader program and disease area objectives.
- Apply expert knowledge of therapeutic focus, disease biology, treatment landscape, and clinically meaningful endpoints to inform study planning, data interpretation, and issue resolution.
- Support cross-study and cross-asset integration of scientific insights to inform development decisions.
- Lead efforts to standardize Clinical Science approaches across the disease area, including medical data review practices, data interpretation principles, and key deliverables, as appropriate.
- Promote consistency in how Clinical Science activities are conducted across studies and programs while allowing for program-specific needs.
- Help establish and maintain standards, expectations, and leading practices for Clinical Science work within the portfolio.
- Support alignment across assets on important disease area considerations, including endpoint interpretation, patient population considerations, safety topics, and emerging scientific issues.
- Advocate for implementation of innovative approaches, including visual analytics, centralized data review, AI-enabled workflows, and other technologies that improve quality and efficiency.
- Provide senior scientific guidance across assigned studies and programs to support high-quality and consistent Clinical Science input.
- Guide interpretation of clinical data across studies, cohorts, and assets to support broader understanding of trends, opportunities, risks, and program implications.
- Support identification and evaluation of important clinical, scientific, and data-related issues and help ensure they are appropriately framed for cross-functional and governance discussions.
- Contribute scientific perspective to protocol development, protocol amendments, study design considerations, endpoint selection, eligibility criteria, biomarker strategy discussions, and other development planning activities.
- Serve as a Clinical Science subject matter resource for their disease area or therapeutic focus across study teams and partner functions.
- Contribute Clinical Science perspective to portfolio discussions, governance reviews, and senior leadership meetings within their disease area.
- Support preparation of clinical and scientific content for governance discussions, program reviews, and senior management communications.
- Present cross-study insights, scientific assessments, and key issues to cross-functional leaders and governance bodies, as appropriate.
- Help ensure that portfolio and governance discussions are informed by sound scientific judgment and clinically meaningful interpretation of available data.
- Translate portfolio priorities into Clinical Science strategies, capabilities, and resource plans.
- Provide direct management for Directors, Principal Scientists, and Clinical Scientists, as appropriate.
- Set clear expectations for scientific quality, strategic thinking, collaboration, and effective communication.
- Support development of Clinical Science talent through coaching, mentoring, feedback, and creation of development opportunities.
- Promote consistency in role expectations and ways of working across Clinical Scientists.
- Foster a culture of accountability, inclusion, continuous learning, and strong team performance.
- Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, Drug Safety and Pharmacovigilance, Translational Medicine, Medical Affairs, and other key partner functions.
- Represent Clinical Science in cross-functional planning, program discussions, and strategic decision-making forums.
- Facilitate alignment across studies, programs, and functions to support consistent scientific approaches and effective portfolio execution.
- Support clear communication of clinical and scientific issues to relevant stakeholders and leadership teams.
- Ensure Clinical Science activities are conducted in accordance with applicable regulatory requirements, company policies, and established procedures.
- Support inspection readiness and appropriate documentation of Clinical Science contributions, as applicable.
- Identify opportunities to improve the quality, consistency, and effectiveness of Clinical Science work across their disease area.
- Maintain awareness of relevant scientific, clinical, and regulatory developments in their disease area or therapeutic focus to inform disease area strategy and Clinical Science practices.
- Sets clear direction aligned with business and organizational priorities.
- Demonstrates strong scientific and strategic judgment in complex and ambiguous situations.
- Builds strong, collaborative relationships across functions and levels.
- Develops people through coaching, feedback, and support for growth.
- Creates an inclusive environment where perspectives are valued.
- Drives accountability and high standards for quality and performance.
- Communicates clearly and effectively with team members, cross-functional partners, and senior leaders.
- Leads through influence in a matrix environment and helps teams align around shared goals.
- Encourages continuous improvement, learning, and thoughtful challenge.
- Balances enterprise thinking with practical decision-making and timely action.
- Advanced scientific or healthcare degree required (e.g., PhD, PharmD), or equivalent, with 8+ years of pharmaceutical, clinical drug development, and/or medical field experience preferred
- Master's degree, preferably in life sciences, with 12+ years of pharmaceutical, clinical drug development, and/or medical field experience
- Bachelor's degree, preferably in life sciences, with 15+ years of pharmaceutical, clinical drug development, and/or medical field experience
- Significant experience in Clinical Development, Clinical Science, clinical drug development, or a related function within the pharmaceutical or biotechnology industry.
- Demonstrated experience providing Clinical Science leadership across multiple studies, programs, or assets.
- Deep therapeutic area expertise, including strong understanding of disease biology, current and emerging treatment landscape, clinically relevant endpoints, and key scientific considerations affecting development.
- Strong understanding of clinical trial design, clinical development strategy, clinical data review, and interpretation of oncology data.
- 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 within a matrix environment.
- Demonstrated 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 management, coaching, and development of scientific staff.
Clinical Research Management, Clinical Sciences, Clinical Trial Planning, Life Science, Matrix Management, Oncology, People Leadership, Study Design, Therapeutic Knowledge, Trial Design
Cross-Functional Teamwork, Development Strategy, Functional Leadership
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. The company complies with conflict discrimination and upholds equal opportunities for all individuals. We provide equal opportunities to employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We are proud to embrace diversity and create an inclusive environment that encourages respectful challenge and collective problem solving.
EEOC Know Your Rights
EEOC GINA Supplement
USA - New Jersey - Rahway
$210,400.00 - $331,100.00
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
Note the salary range above applies to the Primary Location of the position. If a role has other listed locations, different compensation guidelines may apply.
- We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
- We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Job Posting End Date: 11/4/2026
Requisition ID: R422301
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