Director, Clin Dev Compliance, Sops, Disclosure (18-371)

Sarepta Therapeutics Cambridge , MA 02138

Posted 3 months ago

The Company:

Sarepta Therapeutics, Inc. (NASDAQ: SRPT) is at the forefront of precision genetic medicine, having built a world leading pipeline for the treatment of Duchenne muscular dystrophy (DMD). The Company has expanded its portfolio to include Limb-girdle muscular dystrophy (LGMD) and central nervous system (CNS) disorders across several therapeutic modalities, including RNA, gene therapy and gene editing. For more information, please visit www.sarepta.com.

Summary

This newly created position reports into the Sr. Director Clinical Development Operations. He/She will provide the leadership, subject matter expertise, and strategy to drive the optimal clinical development oversight, GCP compliance, SOP, and Disclosure management for Sarepta's outsourced model.

This role will collaborate cross-functionally to understand organizational needs, drive CAPA Management, govern SOP process, manage Disclosure vendor, assist with inspection preparation, support implementations of future capabilities that overall, enhance the effectiveness of compliant clinical trial execution.

Furthermore, this individual will create an effective interface with Clinical Quality Assurance to ensure good clinical practice (GCP) compliance across the global clinical development organization.

Primary Responsibilities

  • Responsible for partnering with heads of various Clinical Development areas to implement a strategic and cohesive approach to Clinical Development GCP Compliance, overall culture, and training requirements

  • Advise senior management of critical quality and compliance related issues and develop corrective actions to mitigate quality and compliance risks

  • Assist Clinical Quality Assurance, as needed, during vendor audits and Support Clinical Operations during oversight assessments

  • Oversee and optimize the Standard Operating Procedures (SOPs), processes, training, and rollout across Clinical Development

  • Assist Clinical Teams in the development of appropriate audit responses, and corrective & preventive action plans

  • Support / Lead inspection preparation activities as required

  • Project management coordination of Clinical Trial Disclosure and Transparency activities to ensure Sarepta sponsored trials are disclosed in accordance to global applicable laws, regulations, and policies

  • Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials

  • Build a Team and Manage to a growing portfolio Qualifications

  • Must enjoy working in a fast-paced, innovative environment. Must be flexible, proactive, efficient, and team player. This is a highly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills. Extensive knowledge of ICH-GCP guidelines and major Health Authority regulations.

  • Bachelor's Degree is required. An advanced degree is highly preferred

  • 10+ years of experience gained with a CRO, biotech, or pharmaceutical company

  • 5+ years of compliance, GCP Function, or clinical project leadership

  • Prior inspection readiness and oversight experience is highly desired

  • This is a highly visible, critical position which will require a self-starter with strong leadership, analytical and interpersonal skills

  • Working knowledge of clinical trial management activities in an outsourced CRO model

  • Experience with delivering effective CAPA management solutions

  • Strong strategic, critical thinking skills with ability to influence senior leadership

  • Excellent communication skills, verbal, written and presenting in English as well as diplomacy, cross-cultural and team skills

  • Ability to management multiple projects simultaneously, prioritize workload for teams and function in fast-paced environment

  • Ability to successfully manage, build, and lead a team

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.


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Director, Clin Dev Compliance, Sops, Disclosure (18-371)

Sarepta Therapeutics