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
Top Skills
What We Do
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.
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