Sarepta Therapeutics
Director, Study Start-Up
Sarepta Therapeutics, Cambridge, Massachusetts, us, 02140
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 limb-girdle 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.
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 We are seeking a 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 Director of Feasibility & Study Start-up will report to the Sr. Director, Clinical Operations, Feasibility & Study Start-up, Early Research and RWE 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: Directing and overseeing the success of Sarepta's clinical trial feasibility process. Leading the development of feasibility and start-up strategies including study-specific plans. Directing and overseeing the success of Sarepta's clinical trial start-up activities. Working with both internal and external vendors. This is a highly cross-functional position, working with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites. The contribution of the candidate directly supports the goals of the Development Operations organization under R&D. This 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 Patients First. The Opportunity to Make a Difference Direct and oversee the feasibility process for Sarepta clinical trials. Direct and oversee the study start-up activities for Sarepta clinical trials. Direct and monitor vendors including the creation of vendor governance charter that details roles, responsibilities, KPIs, and deliverables. Establish study specific meeting series to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO. Candidate will report metrics to larger teams including senior management. Develop and implement feasibility and start-up to support new clinical studies. Lead calls with Sarepta and the CRO to manage feasibility and study start-up activities and ensure the study timelines are achieved. Oversee study feasibility activities including country, site, and investigator selection for participation in Sarepta-lead studies. Develop and foster a culture of new innovative ideas and programs around feasibility to continue growth of the programs and department. Provide guidance and mentoring to junior members of the Study Start-up and Feasibility Team. More about You BA / BS degree with a minimum of 10 years in the pharmaceutical or biotech industry within a clinical operations or project management role or similar. 6+ years' experience in clinical study budget planning, and program implementation. Strong experience with both direct line management and dotted line reporting. Experience in developing feasibility questionnaires. Experience with protocol and ICF development and review. Experience in clinical study start-up. Experience with rare disease / difficult to recruit populations a plus. Experience identifying and managing multiple CROs, vendors, budgets, KPIs. Comprehensive regulatory knowledge, including ICH and GCPs. Exceptional organizational skills and ability to deal with competing priorities. Strong analytical reasoning and problem-solving ability. Excellent PowerPoint slide development and presentation skills. Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary. 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-Remote #LI-TD1 This position is remote. However, 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 $180,000 - $225,000 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.
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https://www.sarepta.com/join-us The Importance of the Role We are seeking a 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 Director of Feasibility & Study Start-up will report to the Sr. Director, Clinical Operations, Feasibility & Study Start-up, Early Research and RWE 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: Directing and overseeing the success of Sarepta's clinical trial feasibility process. Leading the development of feasibility and start-up strategies including study-specific plans. Directing and overseeing the success of Sarepta's clinical trial start-up activities. Working with both internal and external vendors. This is a highly cross-functional position, working with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites. The contribution of the candidate directly supports the goals of the Development Operations organization under R&D. This 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 Patients First. The Opportunity to Make a Difference Direct and oversee the feasibility process for Sarepta clinical trials. Direct and oversee the study start-up activities for Sarepta clinical trials. Direct and monitor vendors including the creation of vendor governance charter that details roles, responsibilities, KPIs, and deliverables. Establish study specific meeting series to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO. Candidate will report metrics to larger teams including senior management. Develop and implement feasibility and start-up to support new clinical studies. Lead calls with Sarepta and the CRO to manage feasibility and study start-up activities and ensure the study timelines are achieved. Oversee study feasibility activities including country, site, and investigator selection for participation in Sarepta-lead studies. Develop and foster a culture of new innovative ideas and programs around feasibility to continue growth of the programs and department. Provide guidance and mentoring to junior members of the Study Start-up and Feasibility Team. More about You BA / BS degree with a minimum of 10 years in the pharmaceutical or biotech industry within a clinical operations or project management role or similar. 6+ years' experience in clinical study budget planning, and program implementation. Strong experience with both direct line management and dotted line reporting. Experience in developing feasibility questionnaires. Experience with protocol and ICF development and review. Experience in clinical study start-up. Experience with rare disease / difficult to recruit populations a plus. Experience identifying and managing multiple CROs, vendors, budgets, KPIs. Comprehensive regulatory knowledge, including ICH and GCPs. Exceptional organizational skills and ability to deal with competing priorities. Strong analytical reasoning and problem-solving ability. Excellent PowerPoint slide development and presentation skills. Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary. 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-Remote #LI-TD1 This position is remote. However, 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 $180,000 - $225,000 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.
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