Associate Director/Director, Medical Operations

United States·CambridgeFull-Timeexecutive

OtherAssociate

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Overview

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe,

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OtherAssociate

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

Summary of Position:

Reporting to the SVP, Global Head of Medical Affairs, the Associate Director/Director, Medical Affairs Operations will provide project management operations support across a variety of exciting initiatives for the Medical Affairs department aligning to the growth and strategy of the function. Drawing on your medical affairs knowledge and project management skills, you will develop project plans, oversee budgets, and ensure the successful completion of key milestones and deliverables. This role will be a key partner within Medical Affairs and partner with cross-functional leaders including Commercial, Patient Advocacy, Clinical Development, and Market Access to act as a central point of coordination, ensuring seamless communication and effective collaboration. This role necessitates a comprehensive understanding of medical affairs and a strong emphasis on project management and strategic thinking.

Provide strategic project management skills to support activities across Medical Affairs and cross-functionally

End to end operational management of Company Sponsored Phase 4 study including oversight of CRO and driving cross-functional alignment with internal stakeholders.

Operationalize the Medical Affairs planning process inclusive of budget planning with Medical Directors.

Provide support to ongoing congress planning initiatives including formatting and finalizing reports and congress specific training materials.

Maintain content and have oversight for Medical Affairs SharePoint databases including budgets, medical resources and other departmental reports repositories.

Monitor the progress of strategic projects by creating project timelines and ensuring deliverables are met on time and within budget.

Provide project support to advisory boards, publications, and congress meetings.

Lead development of monthly Medical Affairs dashboard.

Develop and maintain calendar of meetings across programs, including congresses and internal meetings.

Plan, implement, and maintain new and existing departmental platforms.

Maintain quarterly business updates and support medical affairs management with preparation for presentations at Executive Leadership Team and Senior Leadership Team

Author and maintain Medical Affairs operating processes and SOPs, ensuring the function is audit-ready and launch-ready.

Build operating processes and systems in a fast-moving, high-growth environment with limited infrastructure

Provide operational efficiencies by establishing process improvements, providing guidance to incorporate new technologies, and developing communication tools to engage and inform cross-functional partners.

Collaborate to support publication process within available platforms.

Support content creation and material development for internal meetings utilizing PowerPoint, Smartsheet, and other tools.

Other duties as assigned.

Bachelor’s degree required; advanced degree preferred
Minimum of 5 years of relevant operational experience in the pharmaceutical or biotech industry
Project management, and resource planning/management experience. PMP or other project management certification is a plus.
Minimum of 8 years of company sponsored study management experience within Clinical Operations or Medical Affairs or combination.
Strong knowledge of and ability to implement Medical Affairs concepts and operational practices.
Proven experience with successful management and interaction with medical affairs vendors.
Ability to effectively represent Medical Affairs project management activities with a broader Project Management team and at the cross-functional team level.
Strong cross-functional collaboration skills
Proficiency in the use of project management software and tools, Microsoft Office Suite; experience with Smartsheet
Passion for operationalizing a medical affairs function in keeping with Scholar Rock’s values
Excellent written, verbal, and communication skills
Ability to work independently, prioritize complex information, and problem solve
Ability to thrive in a fast-paced environment with strong ability to simultaneously handle multiple activities, prioritizing and pivoting as necessary.
A minimum of 10-20% travel is required.