Executive Medical Director, Global Clinical Lead

Merck•Boston, MA

2d•Hybrid

About The Position

This role provides senior medical and strategic leadership across global immunology clinical development programs. The focus is on ensuring scientific rigor, patient-centricity, and alignment with asset strategy, portfolio priorities, and regulatory expectations. The position involves leading global clinical development planning, including target product profiles, indication strategy, evidence generation plans, and lifecycle considerations. The individual will act as a senior medical decision-maker within global program teams, offering strategic recommendations on development options, benefit-risk assessments, data interpretation, and key program risks. Responsibilities include driving protocol development, overseeing clinical execution, and ensuring clear documentation of decisions with rationale, risks, and mitigations. Collaboration across various functions such as Clinical Development, Regulatory, Safety, Biostatistics, Translational Medicine, Medical Affairs, and Market Access is crucial for integrated delivery of global development plans. The role also supports and leads regulatory interactions and communicates clinical results through various channels including study reports, regulatory documents, publications, governance forums, and external scientific forums. Engaging investigators, key opinion leaders, advisory boards, and patient communities compliantly is essential to inform clinical strategy and enhance scientific credibility. Additionally, the role involves providing matrix leadership to cross-functional teams and mentoring clinical development colleagues to foster accountability, collaboration, and high-quality execution.

Requirements

Medical Degree, such as MD, DO, or international equivalent, required.
10+ years of experience in immunology, rheumatology, or related autoimmune/inflammatory diseases, with hands-on patient care experience.
5+ years of medical leadership experience within pharma/biotech clinical development.
Prior experience as a Global Clinical Lead, Clinical Program Lead, or equivalent for complex clinical development programs.
Demonstrated experience developing clinical development plans and leading global Phase 2/3 or registrational studies.
Strong understanding of benefit-risk assessment, indication strategy, evidence generation, and lifecycle planning.
Proven ability to lead global clinical trials and cross-functional teams in a complex matrix environment.
Experience supporting or leading health authority interactions, including FDA, EMA, or other major regulatory agencies.
Strong GCP/ICH knowledge and understanding of global regulatory requirements.
Ability to influence senior stakeholders, communicate strategic recommendations clearly, and represent clinical strategy in governance forums.
Excellent cross-functional leadership, communication, and decision-making skills.
Track record of delivering milestones under tight timelines while maintaining quality and scientific integrity.
Willingness to travel domestically and internationally as needed.

Nice To Haves

Board certification preferred.

Responsibilities

Provide senior medical and strategic leadership across global immunology clinical development programs.
Lead global clinical development planning, including target product profiles, indication strategy, evidence generation plans, and lifecycle considerations.
Serve as a senior medical decision-maker within global program teams, providing strategic recommendations on development options, benefit-risk considerations, data interpretation, and key program risks.
Drive protocol development, oversee clinical execution, and ensure decisions are clearly documented with rationale, risks, and mitigations.
Collaborate closely across Clinical Development, Regulatory, Safety, Biostatistics, Translational Medicine, Medical Affairs, Market Access, and other key functions to ensure integrated delivery of global development plans.
Support and lead, as appropriate, regulatory interactions and communicate clinical results through study reports, regulatory documents, publications, governance forums, and external scientific forums.
Engage investigators, key opinion leaders, advisory boards, and patient communities compliantly to inform clinical strategy and enhance scientific credibility.
Provide matrix leadership to cross-functional teams and mentor clinical development colleagues as needed, fostering accountability, collaboration, and high-quality execution.