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About the Role
The Senior Director, Clinical Science, Infectious Disease provides strategic Clinical Science leadership across multiple studies, programs, and assets. 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 is expected to bring deep knowledge of Infectious Disease, including disease biology, current and emerging treatment landscape, relevant clinical endpoints, and key scientific considerations that influence development strategy and study design. This role has a strong strategic orientation and is expected to shape how Clinical Science work is performed across the Infectious Disease 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.
Responsibilities
- 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.
Requirements
- Advanced scientific or healthcare degree required (e.g., PhD, PharmD), or equivalent, and 8+ years of pharmaceutical, clinical drug development, and/or medical field experience preferred -OR- Master’s degree, preferably in life sciences, and 12+ years of pharmaceutical, clinical drug development, and/or medical field experience -OR- Bachelor’s degree, preferably in life sciences, and 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.
Skills
- Clinical Development
- Clinical Research Management
- Clinical Sciences
- Data Quality
- Ethical Standards
- High Performance Team Building
- Infectious Disease
- Matrix Leadership
- Matrix Management
- Medical Monitoring
- New Technology Integration
- People Leadership
- Pharmaceutical Industry
- Regulatory Compliance
- Therapeutic Knowledge
- Trial Design
- Data Interpretations
- Next Generation Science Standards
- Study Design
Location
- USA - New Jersey - Rahway
Work Type
- Hybrid
- Regular
Experience Level
- Senior Director
- 8+ years
- 12+ years
- 15+ years
Education Level
- Advanced scientific or healthcare degree (e.g., PhD, PharmD)
- Master’s degree
- Bachelor’s degree
Salary/Compensations
- $210,400.00 - $331,100.00
Benefits
- 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
- Annual bonus and long-term incentive, if applicable
About the Company
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA
- We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Equal Opportunity
- As an Equal Employment Opportunity Employer, we provide equal opportunities to all 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement
- Learn more about your rights, including under California, Colorado and other US State Acts