Executive Director, Clinical Operations

Sarepta is seeking a dynamic leader to head our clinical operations group. The successful candidate will demonstrate a high level of knowledge of operational methodologies as well as organizational and leadership capabilities, in the field of rare disease drug development. The individual must be well-versed in the principles of clinical research, including ICH guidelines and Title 21 CFR applicable sections. This person will be expected to develop and maintain a world-class clinical operations team through leadership and collaboration, as well as delegation of clinical trial execution to Clinical Trial Managers.

Primary Responsibilities Include:

• Leads the clinical operations team with responsibility for line management, strategic planning and alignment with broader organizational goals.
• Sets overall direction strategy and performance standards for Clinical Operations staff to assure that project objectives are achieved.
• Assists with development and implementation of training plans, annual performance and goals assessments and metrics by which to measure clinical staff performance.
• Directly participates in and has accountability for overall Clinical Operations strategy and performance against key trial metrics.
• Creates a resourcing strategy to support needs for all clinical programs and activities.
• Maintains a quality-focused clinical infrastructure by developing and implementing SOPs consistent with the resourcing strategy; ensures operational processes, systems and standards are consistent with GxP and are adopted, implemented and documented consistently across trials.
• Identifies areas of the clinical infrastructure which are in need of improvement and with consultation with senior management; implements corrective action.
• Identifies and selects high-quality clinical vendors in conjunction with appropriate team members by interviewing and assessing a vendor’s skill set.
• Establishes robust vendor oversight program and establishes regular metrics and budget review.
• Ensures inspection readiness of both active and completed studies and programs.
• Involves in relationships with potential U.S. and ex-U.S. KOLs and trial sites in order to engage and maximize scientific expertise, patient recruitment and data contribution.
• Prepares and presents trial parameters and clinical information to senior management, vendors, and other key stakeholders.
• Champions a mindset and approach that fosters collaboration and consistency across Sarepta.
• Ensures alignment with broader Sarepta strategic initiatives and business needs
• Ensures advocacy / voice of the patient represented in the planning, design and conduct of clinical trials
• Other duties as assigned.

Desired Education and Skills:

• Minimum of a Bachelor’s Degree in related field with at least 15 years of experience in industry and/or a contract research organization and 10 years of experience within a clinical operations function.
• Extensive operations experience in rare disease clinical trials is a must.
• Global clinical trials/program management experience
• Track record of excellence in effective management of multiple projects/priorities and budgets, ranging from early to late stage development programs.
• Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations.
• Extensive experience with vendor oversight and managing external partnerships and relations.
• Demonstration of strong leadership and management abilities.
• Extensive experience managing clinical operations staff.
• Proven ability to lead multifunctional teams and mentor junior staff.
• Ability to remain calm and navigate in a fast-paced and ever-changing small company environment.
• Commitment to the highest standards of patient management and clinical research.
• Excellent verbal, written, interpersonal and presentation skills.

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.