Job Description
Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants."The PositionThe Executive Medical Director role serves as a senior scientific leader within the Global Clinical Development organization. Reporting directly to the Vice President, Clinical Development and Operations, this role provides enterprise-level strategic direction for all General Medicines clinical development programs and carries organizational accountability for portfolio-wide scientific integrity and regulatory outcomes. The Executive Medical Director drives clinical development strategy across multiple assets and therapeutic areas, leads cross-functional teams, and serves as a key external spokesperson for the company's pipeline.
Responsibilities- Strategic Leadership, Portfolio oversight: Own and drive the global clinical development strategy across the General Medicines and assigned assets, providing scientific vision and direction that integrates regulatory, commercial, and medical affairs priorities. Lead or oversee clinical protocol design, ensuring patient-centered, efficient, and strategically aligned protocols. Accountable for the quality, timelines, and outcomes of all clinical programs under remit. Continuously monitor and assess evolving scientific, clinical, and regulatory developments impacting assigned compounds.
- Study Execution, Medical Monitoring and Safety Governance: Collaborate with clinical operations and study team members in oversight of clinical trial conduct, to ensure efficient recruitment, high quality of data and fidelity to protocol, and to minimize compliance and quality risks to enable a decisive readout. Oversee clinical safety surveillance for assigned programs. Define medical monitoring standards and oversight frameworks across CRO and internal teams, and when required, directly act as Medical Monitor for assigned compounds. Provide input to safety monitoring committees, data review boards, and benefit-risk assessments. Provide critical scientific assessment of data readouts to ensure robust interpretation, validity of conclusions, and strategic decision-making.
- Regulatory Strategy and Global Submissions: In collaboration with regulatory affairs, lead regulatory strategy for complex, multi-regional development programs, independently shaping and authoring submission content and negotiation positions with global health authorities. Represent the company in regulatory interactions with FDA, EMA, and other agencies. Provide senior oversight to regulatory documents and ensure alignment across clinical, regulatory, commercial and other functions.
- Organizational Capability and Talent Development: Mentor and develop Medical Directors and senior clinical staff across the organization. Drive continuous improvement in clinical development practices, tools, and frameworks. Champion a culture of scientific excellence, operational rigor, and patient-centered innovation.
- External Engagement and Thought Leadership: Serve as an external spokesperson for the organization's clinical programs. Lead publication strategy, chair or co-chair advisory boards, and build strategic relationships with leading academic centers, key opinion leaders, and patient advocacy organizations globally. Represent the company at major scientific congresses and regulatory forums.
Required Education, Experience & Skills- MD, DO, or MRCP required; advanced business or scientific degree (e.g., MBA, PhD) is an asset.
- Minimum 10+ years of progressive clinical development experience in the biotech or pharmaceutical industry, including demonstrated leadership of multiple simultaneous programs.
- Substantial experience leading NDA/BLA submissions and regulatory interactions with major global health authorities.
- Relevant expertise in general medicines required.
- Expertise in dermatology or pediatric development is an asset.
- Candidates should have a record of fostering and leading high-performing clinical development organizations.
- Deep expertise in ICH, GCP, and global clinical trial regulations with demonstrated ability to shape policy and organizational standards.
- Consistently applies emerging regulatory guidance, scientific evidence, and competitive intelligence to proactively mitigate portfolio-level risk.
- Demonstrates exceptional judgment in complex data interpretation and organizational decision-making.
- Leads and aligns large, matrixed, cross-functional teams with an enterprise mindset; models inclusive leadership and fosters high-performing cultures. Operates with a high level of autonomy and executive accountability across all aspects of clinical development.
- Proven ability to set strategic direction, manage competing priorities, and lead organizations through ambiguity and change.
- Upholds the highest standards of scientific integrity and professional ethics.
- Exceptional written and oral communication skills, with demonstrated experience presenting to executive leadership and external stakeholders. Fluent in written and spoken English. Significant travel may be required to support clinical programs, regulatory meetings, and external engagement globally.
Secondary Job Description
