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Scholar Rock · 2 hours ago

Director, CMC Project Management

Cambridge, MA

Full-time

Onsite

Director/Executive

$190K/yr - $260K/yr

8+ years exp

Scholar Rock is a biopharmaceutical company focused on developing life-changing therapies for serious diseases. They are seeking a Director of CMC Project Management to lead global CMC activities for their portfolio of biologics, ensuring effective project management and alignment with program goals.

BiopharmaBiotechnologyMedicalTherapeutics

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

Qualification

Biologics CMC experienceRegulatory CMC knowledgeProject management expertiseOutsourced CDMO modelProject management toolsAnalytical skillsCommunication skillsProblem solvingCritical thinkingOrganizational skills

Required

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