Associate Director, GCP Quality Assurance - Scholar Rock Cambridge, MA Bookmark Share Print 45 0 0

Listing Description

Scholar Rock is a Phase 3, clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.

Summary of Position:

Playing a critical role within Scholar Rock, the Associate Director, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Associate Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Scholar Rock sponsored Clinical Studies.

This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems at Scholar Rock as we grow and mature organizationally. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities. 

Position Responsibilities
  • Act as GCP QA Program Lead while working with internal stakeholders to ensure overall study compliance from risk-based principles. Provide expert GCP consultation within the Scholar Rock organization.
  • Work with internal and external Study Team members and develop and execute strategic plans to identify, mitigate, monitor and report site, study and program level compliance risks.
  • Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the Quality Organization as needed.
  • Coordinate with the Scholar Rock Vendor Audit Manager to ensure successful planning, execution and closure of GCP Vendor audits including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization vendors, IRB/IECs and other vendors.
  • Manage the Scholar Rock Clinical Investigator (CI) Site Audit program. Coordinate with Study Team members to determine CI sites to be audited per study via risk-based criteria. Coordinate with Study Team members and third-party auditors to ensure CI site audits are appropriately scoped, planned executed and closed.
  • Determine if CI Site audit observations may represent study-wide or program-wide risks and ensure Impact/Risk Assessments and Study-wide/Program-wide CAPAs are adequate.
  • Coordinate with Scholar Rock Senior Management, Functional Area Leads, and third-party vendors, on Inspection Preparation activities including mock inspections, gap assessments, resolution and mitigation of identified compliance concerns. Provide key support during and after regulatory inspections.
  • Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities at Scholar Rock.

  • Candidate Requirements
  • Bachelor’s degree in the Life Sciences with 10+ years in pharmaceutical or biotech drug development. Advanced degree preferred.
  • Minimum 5 years of experience in Clinical QA, including both external and internal auditing.
  • Demonstrated experience working with clinical trial teams.
  • Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.
  • Previous experience facilitating and/or supporting Regulatory Authority Inspections.
  • Direct experience in development and oversight of Quality Management Systems.
  • Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting. 
  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels.
  • Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees

    Listing Details

    • Citizenship: Not Provided
    • Incentives: Not Provided


    • Education: Not Provided
    • Travel: Not Provided
    • Telework: Not Provided

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