Executive Director Clinical Operations
Executive Director Clinical Operations
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$ 248000 - 310000
1 Vacancy
Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
The Executive Director Clinical Operations Therapeutic Area (TA) Lead will function in a strategic leadership role accountable for managing all assets and clinical programs within assigned TA. The TA Lead is responsible for driving program teams within the TA towards corporate and asset goals. The TA Lead is expected to be a seasoned leader that can provide technical expertise and inspire and motivate their teams. This is a highly visible role within Development Operations and R&D. The TA Lead will assume a functional leadership role involving hiring and headcount planning and envisioning and driving departmental and crossfunctional initiatives.The Opportunity to Make a Difference
- Oversee multiple assets and clinical programs within an assigned TA
- May sit on Global Program Teams as Clinical Subteam representative and/or colead Clinical Subteams with Clinical Development
- Will oversee Clinical Operations Program Lead(s) responsible for assigned clinical programs
- Contributes to and oversees the development of CDPs including scenario planning highlevel forecasting of timelines assesses program level feasibility estimation and allocation of resources and budget and development of highlevel operational strategies
- Accountable for meeting all operational deliverables in accordance with the timeline cost and quality commitments
- Ensures internal consistency across TA and ensures alignment of operational program to the development team goals
- Interfaces with key internal and external stakeholders (senior leadership KOLs advocacy groups external partner leadership teams etc.
- Provides functional leadership and clinical trial subject matter expertise to the program and clinical operations teams
- Mentors and coaches clinical operations TA team (direct and dottedline reports) provides timely feedback to Head of Development Operations regarding staffing needs and individual performance feedback
- Provides performance talent and resource management and succession planning
- Identifies recruits hires and develops staff as well as oversees their work to ensure all department goals deliverables and objectives are met
- Ensures that employees are appropriately trained and comply with company and regulatory standards
- Creates a positive work environment by encouraging mutual respect creativity and accountability
- Actively participates in vendor/external partnership governance
- Participate in and/or lead working groups and/or initiatives within the Development Operations organization or cross functionally (at least 25 allocation to nonprogram specific work)
- Up to 6 direct reports of any level
More about You
- Experience with managing and demonstrating oversight of CROs vendors and consultants
- Strong experience with both direct line management and dotted line reporting
- Extensive knowledge and application of current FDA Regulations GCP and ICH guidelines in clinical trials
- Prior regulatory inspection experience preferred
- Experience developing and implementing programlevel plans including reporting tools timelines budgets
- Ability to collaborate effectively with the study team crossfunctional team members and external partners (including investigator and site staff) using collaborative negotiation skills
- Proficient written and verbal communication skills
- Strong computer skills including knowledge of Excel Word PowerPoint Outlook and MS Project
- Position may require some travel; travel to the office is expected for critical activities
- Bachelors degree in health sciences or related field
- Minimum of 12 years of experience in clinical research with at least 8 years of experience directing and implementing clinical program strategy
- Line management experience required
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Director
Employment Type
Full-Time
