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Senior Director, Medical Operations

scholarrock · 30+ days ago

Cambridge, MA

Negotiable

Full-time

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Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.

Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

Summary of Position:

Reporting to the Global Head of Medical Affairs, the Senior Director, Medical Affairs Operations is a pivotal role that offers strategic project management expertise and oversight to support the medical affairs team in the areas of project management, independent medical education, ISS, field medical excellence and financial accountability with an eye toward process improvement This role necessitates a comprehensive understanding of medical affairs and a strong emphasis on project management, strategic thinking with a strong eye to tactical execution. This role will act as a central point of coordination and leadership, ensuring seamless communication and effective collaboration in Medical Affairs. This individual will also play a key role in driving strategic Medical Affairs initiatives, managing critical projects, and ensuring the overall efficiency and effectiveness of the medical affairs team.

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.

Position Responsibilities:

Serve as strategic and operational partner to the Medical Affairs Leadership Team (MALT) and other senior leaders, ad hoc, within the organization.
Support the team on developing short- and long-term priorities aligned to the Medical Objectives.
Partner with different functions within medical affairs (therapeutic area, field medical team, scientific communications/ information, and real-world evidence) to enhance the organization’s effectiveness in decision making and delivery, facilitate communication and creation, maintenance, and drive of timelines to keep consultations, studies and projects on schedule; this includes overall project planning, but also specific deliverables during medical affairs initiatives.
Organize efforts across the team as needed to provide timely and reliable information to support decision making, planning and communications. Ex. IIS, Grants, IME prioritization, and vendor assessment.
Oversee day-to-day operations within Medical Affairs, ensuring smooth and efficient functional execution
Provide insights and guidance on strategic decisions and operational challenges. Focus on immediate and short-term (<2 years) strategic planning within Medical Affairs.
Facilitate functional goal setting process and track progress, results, and performance.
Assist in identifying areas of improvement in process/policy, develop recommendation/plans to streamline and simply the Medical Affairs operating model.
Partner with finance and the medical affairs team to establish budget templates and coordinate efforts for and provide guidance on monthly/quarterly/annual/LRP forecasting and budget activities including purchase orders and accounts payable.
Monitor and manage budget and resources ensuring optimal allocation and fiscal responsibility. Key liaison and interface with finance organization with regards to financial impact of strategic initiatives and investments.
Support the head of medical affairs in the partnership with HR to develop and analyze headcount resources within the organization me.
Plan and implement Medical Affairs Leadership Team (MALT) meetings, agendas, content, and actions to maximize team effectiveness and ensure optimal value is created.
Partner with the MALT to ensure a high-performance team culture and talent development.
Support the MALT on executive deliverables (e.g. updates to the CEO, materials to the Board of Directors).
Actively partner across R&D and other teams to ensure alignment on organizational plans and activities.
Oversee and ensure tracking and movement with Medical Affairs SOPs and work with Quality to track compliance issues to completion.
Ensure the appropriate development and tracking of metrics for Medical Affairs.
Establish and maintain cross-functionally integrated project plans/timelines and accurately track and provide timely reporting on progress.
Other duties as assigned.

Candidate Requirements:

Bachelor’s degree required; advanced degree preferred.
5-8 years of experience in a project management role with at least 5 years of direct experience in medical affairs operations or skills adjacent.
Demonstrated in depth knowledge and experience in planning, management, and oversight of activities and deliverables, preferably within Medical Affairs. PMP or other project management certification is a plus.
Strong knowledge of and ability to implement Medical Affairs concepts and operational practices.
Proven experience with successful management and interaction with medical affairs vendors.
Proven track record of managing multiple projects and/or programs concurrently.
Deep knowledge and ability to use project management software and tools, as well as Smartsheet.
Ability to effectively represent Medical Affairs project management activities with a broader Project Management team and at the cross-functional team level.
Experience in strategic planning and execution and developing and implementing processes, including process improvement, and procedures.
Ability to design, implement and lead multiple projects, setting deadlines, assigning responsibilities, and monitoring progress towards goals.
Strong analytical and problem-solving skills, with a focus on planning, prioritization and organization to advance execution and deliverables.
Excellent interpersonal and communication skills (communication, writing and presentation skills).
Ability to work independently, prioritize complex information, and problem solve
A minimum of 10-20% travel is required.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Last updated on Jan 18, 2025

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