Director, CMC Project Management
Scholar RockCambridge, MA
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Job Description
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:
Scholar Rock is seeking a highly experienced and organized leader to provide global CMC leadership across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. As the Director, CMC Management, you will be accountable for CMC project and portfolio management activities for our products working closely with CMC technical leads and cross-functional CMC teams. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.
Position Responsibilities:
- Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs
- Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines
- Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success
- Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs
- Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program
- Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas
- Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration
- Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time.
Candidate Requirements:
- Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience
- 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects
- Experience in achieving CMC objectives through an outsourced CDMO model
- Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders
- Strong analytical, problem solving and critical thinking skills; highly organized.
- Proven track record of successful project management of complex drug development programs in a fast-paced environment
- Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards)
- Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment
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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