{"id":3315919,"url":"https://alion.io/job/sarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility","title":"Associate Director, Clinical Operations Program Lead, Study Start-up & Feasibility","company":{"id":1949959,"name":"Sarepta","domain":"sarepta.com","url":"https://alion.io/company/sarepta","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":160800,"max":201000,"currency":"USD","period":"year","gross":null,"usd_annual":201000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-28T18:51:48Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Why Sarepta? Why Now?\nSarepta 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 and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our next-generation siRNA platform is focused on chronically administered therapies for neurodegenerative and pulmonary diseases.\nWe’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.\nWhat Sarepta Offers\nAt 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:\nPhysical and Emotional Wellness\n\nFinancial Wellness\n\nSupport for Caregivers\n\nFor a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us\nThe Importance of the Role\nWe are seeking an associate director-level candidate with clinical operations experience, with specific expertise in feasibility and study start-up, who is interested in applying their experience to develop, build out, and implement innovative feasibility and study start-up activities within Sarepta that positively impacts our clinical programs.The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. Additionally, the candidate will work with early research and other stakeholders to build out the oversight model for Feasibility & Study Start-up. The candidate will drive the study start-up activities and be responsible for oversight of timelines and goals with respect to our clinical studies. The candidate will be responsible for 1) directing and overseeing the success of Sarepta’s clinical trial feasibility process, 2) leading the development of feasibility and start-up strategies including study-specific plans, 3) directing and overseeing the success of the Sarepta’s clinical trial start-up activities, 4) and working with both internal and external vendors.\nThis is a highly cross-functional position, collaborating with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites.\nThe contribution of the candidate directly supports the goals of the Development Operations organization under R&D.\nThis is a great opportunity for an individual with an operational background and innovative mindset to help us accelerate study execution to support Sarepta’s goal of Patient’s First.\nThe Opportunity to Make a Difference\nPrimary Responsibilities Include:\nDevelop and implement the feasibility and start-up strategies to support the success of Sarepta clinical studies.\nGather cross-functional, country-level input to inform robust feasibility strategies.\nDevelop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.\nEstablish study specific meeting series to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO. The candidate will report metrics to larger teams including senior management. \nLead calls with Sarepta and the CRO to manage feasibility and study start-up activities and ensure the study timelines are achieved. \nOversee study feasibility activities including country, site, and investigator selection for participation in Sarepta-lead studies. \nFoster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth. \nProvide guidance and mentoring to junior members of the Study Start-up and Feasibility Team.\nCreate reporting tools to measure ongoing activities and other key performance, quality, and effectiveness indicators.\nPartner with Clinical Operations and CRO teams, and other key stakeholders to implement innovative feasibility efforts including collection of data within CTMS.\nSupport and or lead the development of Charters or SOPs as it relates to Study Start-up and Feasibility. \nMay have direct reports.\nMore about You\nDesired Education and Skills:\nBA / BS degree in a related field; 10+ years related experience in the pharmaceutical or biotech industry within a clinical operations or project management role or similar \nExperience in clinical study budget planning, and program implementation \nExperience with both direct line management and dotted line reporting\nExperience in developing feasibility questionnaires\nExperience with protocol and ICF development and review\nExperience in clinical study start-up\nExperience with rare disease / difficult to recruit populations a plus\nExperience identifying and managing multiple CROs, vendors, budgets, KPIs. \nComprehensive regulatory knowledge, including ICH and GCPs\nExceptional organizational skills and ability to deal with competing priorities\nStrong analytical reasoning and problem-solving ability\nExcellent PowerPoint slide development and presentation skills\nAbility to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary\nWhat Now?\nWe’re always looking for solution-oriented, critical thinkers.\nSo, 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.\n#LI-HybridThis 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.","description_format":"text","description_chars":6807,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T05:27:59Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":28,"reasons":["seen:2","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":201000,"is_top_pay":false},"html_url":"https://alion.io/job/sarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility","json_url":"https://alion.io/job/sarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility.json","meta":{"generated_at":"2026-10-28T20:13:16Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":28031,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1949959},"rest":"https://alion.io/mcp/rest/get_company?id=1949959"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fsarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fsarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/sarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsarepta-associate-director-clinical-operations-program-lead-study-start-up-feasibility"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3315919}},{"tool":"search_jobs","arguments":{"company":"sarepta.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3315919},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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