Associate Director, Clinical Operations Lead at Sarepta Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

201000.0

Posted On

01 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Project Oversight, CRO Management, Study Management, Risk Mitigation, Budget Management, Communication Skills, Collaboration, Regulatory Compliance, Trial Execution, Team Leadership, Clinical Research, Data Analysis, Problem Solving, Negotiation Skills, SOP Development

Industry

Biotechnology Research

Description

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re 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 work-life 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: https://www.sarepta.com/join-us The Importance of the Role The Associate Director, Clinical Operations Lead, is responsible for the planning, implementation, conduct, and oversight of clinical operations for assigned studies or program. This individual is expected to provide leadership as well as line management within Development Operations and guidance with regards to operational deliverables. The AD COL may lead complex studies with the support of one or more Clinical Operations Leads (COLs) and/or may be responsible for project oversight across studies within a program. The Opportunity to Make a Difference Serve as the subject matter expert within clinical operations for the planning and execution of studies across all phases May lead complex studies with the support of one or more COLs, or may provide project oversight to one or more studies on a large program Oversees Clinical Research Organizations (CROs), vendors and consultants involved with the clinical trials Serves as the point of contact for protocol execution May lead the Clinical Trial Team (CTT) and/or may participate in the program Clinical Sub Team May support the Clinical Operations Program Lead (COPL) to operationalize and execute the Clinical Development Plan (CDP) Oversees junior team members and ensures alignment with any supporting COLs assigned to studies Establishes study timelines in line with company goals and ensures accurate tracking and reporting of study metrics and progress through completion of study dashboards Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the COPL Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs Develops, reviews and/or consults on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates Responsible for communication and escalation of study related issues to the COPL Provides enrollment forecasting to internal stakeholder, such as Clinical Supply, at agreed upon frequency Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed, or delegates activity with oversight Participates and responds to Quality Assurance and/or regulatory authority inspection audits In conjunction with CRO and appropriate internal stakeholders, facilitates the development of trial budgets and execution of clinical trial agreements and other relevant documents Manages the clinical trial budget and provides financial reporting and projections to Finance Leads creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary May serve as an escalation point for more clinical operations team study team members internally and with vendors Assume leadership role in operational improvement initiatives (e.g., SOP development, training etc.) Up to ~4 direct reports consisting of CTAs, COLs, Sr. COLs More about You Experience in management of CROs, vendors and consultants Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets Proficient written and verbal communication skills Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project Position may require some travel Bachelor’s degree in health sciences or related field Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management with strong experience with study phases I-IV, global trials, and with complex trial designs Program-level experience preferred. Rare disease study management is recommended. • Line management experience required What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re 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. #LI-Hybrid Blank This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. 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. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Responsibilities

The Associate Director, Clinical Operations Lead is responsible for the planning, implementation, conduct, and oversight of clinical operations for assigned studies or programs. This role includes leading complex studies, overseeing CROs and vendors, and ensuring compliance with regulations.