Associate Director/director, Early Access Program - Cambridge, United States - Scholar Rock

Scholar Rock

Verified Company

Cambridge, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

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.

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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 crossfunctional review meetings, vendor meetings, investigator meetings and other meetings, as required
Bachelor's degree required
5+ years of multidisciplinary 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_.