Senior Director, Clinical Science, Oncology Early Development (Hybrid)

Job Description

The Senior Director, Clinical Science, Oncology Early Development is responsible for providing strategic Clinical Science leadership for novel assets from candidate transition through first-in-human development and clinical clinical proof-of-concept. Reporting to the Executive Director, this role contributes to the early development and scientific platform strategy by applying deep expertise in early-phase oncology, translational medicine, biomarker strategy, and first-in-human (FIH) trail design to shape development plans, strengthen scientific rigor and enable objective, data-driven decision-making across the early oncology portfolio.

The Senior Director integrates emerging clinical, pharmacokinetic, pharmacodynamic, biomarker, safety, and external scientific evidence to inform indication strategy, dose escalation and optimization, cohort expansion, and proof-of-concept assessments. The role partners closely with Section Heads, Asset Leads, Early Program Development Team Leads, study teams, and cross-functional leaders to guide study design, data interpretation, issue resolution, and program decisions. 

This role has a strong strategic orientation and is expected to shape how Clinical Science work is performed across the Oncology Early Development 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.

Key Responsibilities

Early Development and Clinical Science Strategy

• Provide strategic Clinical Science leadership across Oncology Early Development, including multiple studies, programs, and assets.
• Contribute to early clinical development strategy from candidate transition through first-in-human evaluation and clinical proof-of-concept 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, Early Program Development Team Leads, and cross-functional leaders to support alignment of Clinical Science activities with broader program and disease area objectives.
• Integrate disease biology, mechanism of action, translational evidence, competitive landscape, and emerging internal and external data to identify development opportunities, risks, and key decision points.
• Connect insights across studies and assets to inform portfolio decisions and future development.

Standardization and Scientific Consistency

• Establish and advance consistent Clinical Science standards for early development planning, medical data review, dose-escalation meetings, data interpretation, and key deliverables.
• Promote scientific consistency across studies while preserving flexibility for asset-specific biology, modality, and development questions.
• Identify and implement improvements that strengthen decision quality, operational efficiency, documentation, and inspection readiness.
• Maintain awareness of emerging oncology science, early development methodologies, regulatory expectations, and external innovations relevant to the portfolio.
• Help establish and maintain standards, expectations, and leading practices for Clinical Science activities within the portfolio.
• Advocate for the implementation of innovative approaches, including visual analytics, centralized data review, AI-enabled workflows, and other technologies that improve quality and efficiency.

Strategic Scientific Leadership

• 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 a broader understanding of trends, opportunities, risks, and program implications.
• Support the identification and evaluation of key 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 expert for Oncology Early Development across study teams and partner functions.

Portfolio and Governance Contribution

• Contribute Clinical Science expertise to portfolio discussions, governance reviews, and senior leadership meetings within the Oncology Early Development organization.
• Support the development 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.

People Leadership and Capability Building

• 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 the development of Clinical Science talent through coaching, mentoring, feedback, and the creation of development opportunities.
• Promote consistency in role expectations and ways of working across Clinical Scientists.
• Foster a culture of accountability, collaboration, continuous learning, and high performance.

Cross-Functional Leadership

• 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.

Compliance and Continuous Improvement

• 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.

Core Leadership Skills

• 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 diverse 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.

Education

• 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

Experience

• Significant experience in Clinical Development, Clinical Science, clinical drug development, or a related function within the pharmaceutical or biotechnology industry, with substantial responsibility in early-phase development.
• Demonstrated leadership of first-in-human and early-phase oncology studies, including dose escalation, dose optimization, cohort expansion, and proof-of-concept planning.
• Deep understanding of oncology disease biology, novel mechanisms and modalities, translational medicine, biomarker-driven development, PK/PD, and safety and tolerability assessment.
• Strong understanding of clinical trial design, clinical development strategy, clinical data review, and interpretation of oncology data.
• Experience contributing to protocols, regulatory submissions, safety reviews, health authority interactions, governance discussions, and cross-program planning.
• Experience working effectively within cross-functional teams in a matrixed environment.
• Demonstrated ability to integrate information across studies and programs to support scientific and business decision-making.
• Excellent communication, influence, and executive presentation skills.
• Demonstrated people leadership experience, including management, coaching, and development of scientific staff.

Travel 0-15%

clinicalsci2026

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Required Skills:

Clinical Development, Clinical Research, Clinical Sciences, Clinical Study Management, Clinical Trial Development, Clinical Trial Management, Clinical Trials Operations, Disease Research, Early Phase Clinical Trials, Oncology

Preferred Skills:

Cross-Functional Teamwork, Decision Making, Leadership

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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:

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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.

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$210,400.00 - $331,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: 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

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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:

11/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.