Associate Director/Director, Early Access Program

Cambridge, MA
Development – Medical Affairs /
Full-Time /
Hybrid
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:

The Associate Director/Director, Early Access Program, is responsible for day to day management and operations of our early access programs (EAPs) including management of vendors and sites participating in our programs.  This individual also works closely with cross-functional teams to ensure that these programs are conducted in a timely, efficient fashion and in a manner compliant with global regulatory guidelines and SOPs.

Position Responsibilities:

    • Provide operational expertise and project management support for the EAPs with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements.
    • Manages the operational aspects of the Early Access Program with a key responsibility on vendors and site management:
    • Manages vendor, providing sponsor oversight of operational activities (e.g., supply chain labeling, packaging and shipping to site; agile execution of the site and patient approval processes), develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
    • Participates in preparation and approval of protocol, informed consent, physician and patient facing documentation
    • Prepares reports, metrics and updates for internal stakeholders
    • Proactively identifies potential issues/risks and recommends/implements solutions
    • Recommends and implements innovative process ideas to successfully impact the operations of the EAP
    • Organizes and manages internal cross-functional review meetings, vendor meetings, investigator meetings and other meetings, as required

Candidate Requirements:

    • Bachelor’s degree required
    •  5+ years of multi-disciplinary experience in the biotechnology / pharmaceutical industry with experience in EAPs
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees