Senior Manager, Medical Affairs Lead

Senior Manager, Medical Affairs Lead

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.

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.
• Coordinate and oversee 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.

Essential Skills

• 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.
• Proven ability to manage 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.
• 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.

Work Environment

This role is based in a hybrid work environment in Waltham, MA, with an expectation to work on-site three days per week.

The setting combines in-office collaboration with remote flexibility, supporting close interaction with cross-functional teams in Medical Affairs and related functions.

The organization focuses on discovering and advancing innovative, life-transforming therapeutics for people living with genetically driven neuromuscular diseases, leveraging a platform designed to deliver targeted therapeutics to muscle and the central nervous system.

The culture emphasizes scientific innovation, patient-centered impact, and cross-functional partnership across a broad pipeline that includes clinical and preclinical programs in neuromuscular and rare diseases.

Job Type & Location

This is a Contract position based out of Waltham, MA.

Pay and Benefits

The pay range for this position is $90.00 - $120.00/hr.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment.

Benefits are subject to change and may besubject to specific elections, plan, or program terms.

• If eligible, the benefitsavailable for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Workplace Type

This is a hybrid position in Waltham, MA.

Application Deadline

This position is anticipated to close on Jul 13, 2026.

Equal Opportunity Employer & Legal Notices

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminal penalties and civil liability.

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates.

AI helps assess applications and qualifications, but final decisions are made by our hiring team.

By applying, you acknowledge and agree that your application may be reviewed using AI tools.

If you would like to request a reasonable accommodation, you may email actalentaccommodation@actalentservices. com for other accommodation options.

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