Senior Manager, Medical Affairs Lead

Responsibilities

• Lead the operational execution of a U.S.-based real-world evidence study within the Medical Affairs organization, ensuring all activities align with strategic objectives and regulatory requirements.
• Serve as the primary study lead responsible for end-to-end study management, including planning, execution, monitoring, and close-out of post-marketing, observational, registry, or Phase 4 studies.
• Provide day-to-day oversight of CROs and external vendors, ensuring adherence to scope, quality standards, timelines, and budget.
• Drive study startup activities, including operational planning, site and vendor activation, and coordination of study documentation and systems.
• Manage study timelines, budgets, risks, and operational deliverables, proactively identifying issues and implementing effective risk mitigation strategies.
• Lead cross-functional study teams without direct reporting lines, fostering collaboration across Medical Affairs, Clinical, Data Management, Biostatistics, and other relevant functions.
• Cover coordination and oversight of the use of EDC and other clinical research technologies to support efficient and accurate data collection and study conduct.
• Ensure clear, consistent communication with internal stakeholders and external partners, providing regular status updates and escalating issues as needed.
• Contribute to the development and refinement of RWE operational processes and best practices within the organization.
• Support the preparation and review of study-related documents and materials, such as operational plans, charters, and vendor scopes of work.
• Partner with internal teams to align study execution with broader medical strategy, including evidence generation plans for neuromuscular and other rare disease indications.
• Maintain strong stakeholder relationships, facilitating decision-making and alignment across multiple internal and external parties.

Requirements

• Bachelor's degree in Life Sciences, Public Health, or a related discipline.
• 8+ years of clinical operations, medical affairs operations, or study management experience within biotech, pharmaceutical, CRO, or related environments.
• Extensive experience overseeing post-approval, observational, Phase 4, registry, or other real-world evidence studies.
• Strong CRO oversight and vendor management experience, including performance monitoring and issue resolution.
• Demonstrated success leading complex, cross-functional study teams without direct authority over team members.
• Prioritizing study timelines, budgets, risks, and operational deliverables in a fast-paced environment.
• Working knowledge of EDC systems and clinical research technologies used in observational and interventional studies.
• Strong organizational skills with the ability to manage multiple priorities and projects simultaneously.
• Excellent verbal and written communication skills, with the ability to present information clearly to diverse stakeholders.
• Effective stakeholder management skills, including the ability to influence and build consensus across functions.

Essential Skills

• Experience in Medical Affairs research leadership, RWE operations, or similar roles such as Medical Affairs Research Lead or RWE / Real-World Evidence Operations Lead.
• Background as a Clinical Trial Manager (CTM) or similar role, particularly within a Medical Affairs context.
• Professional experience in small or mid-sized biotech or pharmaceutical organizations.
• Rare disease experience, particularly in neuromuscular indications, is a strong plus but not required.
• Familiarity with neuromuscular disease research areas, including conditions such as myotonic dystrophy type 1, muscular dystrophy, facioscapulohumeral muscular dystrophy, or Pompe disease.
• Ability to lead cross-functional initiatives and influence without direct reports, fostering collaboration and accountability.
• Comfort working with RFP processes and CRO selection or evaluation activities.
• Commitment to high-quality evidence generation and patient-focused outcomes in genetically driven neuromuscular diseases.

Additional Skills & Qualifications

• Experience in Medical Affairs research leadership, RWE operations, or similar roles such as Medical Affairs Research Lead or RWE / Real-World Evidence Operations Lead.
• Background as a Clinical Trial Manager (CTM) or similar role, particularly within a Medical Affairs context.
• Professional experience in small or mid-sized biotech or pharmaceutical organizations.
• Rare disease experience, particularly in neuromuscular indications, is a strong plus but not required.
• Familiarity with neuromuscular disease research areas, including conditions such as myotonic dystrophy type 1, muscular dystrophy, facioscapulohumeral muscular dystrophy, or Pompe disease.
• Ability to lead cross-functional initiatives and influence without direct reports, fostering collaboration and accountability.
• Comfort working with RFP processes and CRO selection or evaluation activities.
• Commitment to high-quality evidence generation and patient-focused outcomes in genetically driven neuromuscular diseases.

About the Role

The Senior Manager, Medical Affairs Lead (Senior Manager/Associate Director, RWE Operations) leads the operational execution of a U.S.-based real-world evidence study within the Medical Affairs organization. This role serves as the primary study lead, overseeing CRO partners, driving study startup activities, managing timelines and risks, and guiding cross-functional teams to deliver high-quality post-approval and observational research that supports medical and commercial objectives.