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Scholar Rock

Posted 2 months ago

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Associate Director, Clinical Operations Compliance

Cambridge, MAHybridFull-time

AI Summary

Associate Director, Clinical Operations Compliance at Scholar Rock leads oversight of clinical operations compliance, ensuring adherence to SOPs, GCP, ICH, FDA, and EMA requirements, and prepares programs for inspections.

About this role

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:

Scholar Rock is looking for an associate or director-level subject matter expert to build clinical operations compliance while upholding our core values and staying true to our mission. Reporting to the Head of Clinical Operations, the Director, Clinical Operations Compliance will play a key role in oversight of adherence to standard procedures and support of issue management for the clinical programs, and ensuring programs are inspection ready.

Position Responsibilities

  • Ensure consistency in the implementation of clinical project plans by providing reviews and support template development or refinement.
  • Lead initiatives, create process/ standards, and ensure consistency, communication, and change management across Clinical Operations, specifically related to SOP and work instruction creation and management, outsourcing, and compliance.
  • Partner with cross-functional team members within Regulatory, Quality, Data Sciences, Clinical Research, Pharmacovigilance, and other key cross-functional groups to support department compliance objectives.
  • Develop TMF standards and oversight in support of inspection readiness Develop or refine Standard Operating Procedures (SOPs), vendor endorsement team process, and functional builds, e.g. TMF standards.
  • Support outsourcing partnerships through issue escalation, resolution, and CAPA mediation and documentation as a support to governance oversight.
  • Provide compliance oversight of clinical operation activities (trial management, site monitoring, vendor management, TMF, data operations, IMP management, and closeout activities, etc.) for clinical trials.
  • Review key documents in conjunction with other functional area leads (e.g. protocols, SOPs, project plans, and inspection requests, etc.).
  • Serve as the Clinical Operations compliance subject matter expert for SOPs, GCP, ICH, FDA, EMA, and other applicable regulatory requirements, ensuring practical application/compliance across study teams and vendors throughput the trial lifecycle.
  • Issue escalation, documentation, and resolution in partnership with Clinical Operations and Quality Assurance business practices.
  • Ensure consistent implementation of training and learning, including responsibility for managing functional training matrices and adherence by personnel, as well as oversight of vendor training and learning processes.
  • Contribute to global clinical / regulatory submissions.
  • Responsible for assisting in inspection readiness activities, including mock and site inspections.
  • As a subject matter expert, actively educate, engage with and seek input from key stakeholders to bolster organizational effectiveness and efficiency.
  • May require travel, including international travel.
  • Flexible to support in-office days.

    • Candidate Requirements

  • Bachelor’s Degree (scientific discipline preferred); advanced degree preferred
  • Minimum 10 years of experience in a biotech/pharmaceutical/ CRO setting; minimum 8 years of clinical operations experience; minimum 5 years in a supervisory role
  • Proven record of success supporting complex drug development trials, including inspection readiness preparation and experience with positive outcomes from inspections
  • Demonstration of effective leadership through vision for her/his team, coaching and mentoring, and organizational development
  • Highly organized, outcome oriented, self-motivated performance
  • Comfortable in a fast-paced environment with the ability to adapt to change
  • In depth knowledge and understanding of all aspects of clinical trials
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
  • Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
  • Excellent knowledge and experience with federal regulatory requirements and guidelines for Good Clinical Practice
  • Outstanding oral and written communication skills including authoring and driving the development of SOPs and other key trial documents

    • Skills

    CAPAClinical OperationsEMAFDAGCPICHSOPsTMF

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