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.
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.
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.