Executive Medical Director, Global Clinical Lead

The businesses of Merck KGaA, Darmstadt, Germany•Boston, MA

5d•$229,800 - $381,700•Hybrid

About The Position

This role provides senior medical and strategic leadership across global immunology clinical development programs. The Executive Medical Director ensures scientific rigor, patient-centricity, and alignment with asset strategy, portfolio priorities, and regulatory expectations. Key responsibilities include leading global clinical development planning, serving as a senior medical decision-maker within global program teams, driving protocol development, and overseeing clinical execution. The role involves close collaboration with various functions such as Clinical Development, Regulatory, Safety, Biostatistics, Translational Medicine, Medical Affairs, and Market Access. The Executive Medical Director will support and lead regulatory interactions, communicate clinical results, and engage with investigators, key opinion leaders, advisory boards, and patient communities. Additionally, the role involves matrix leadership to cross-functional teams and mentoring clinical development colleagues.

Requirements

Medical Degree, such as MD, DO, or international equivalent, required; board certification preferred
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

Responsibilities

Provide senior medical and strategic leadership across global immunology clinical development programs.
Ensure scientific rigor, patient-centricity, and alignment with asset strategy, portfolio priorities, and regulatory expectations.
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.
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.