Associate Director, Clinical Operations Lead, Study Start-up & Feasibility

Sarepta Therapeutics•Cambridge, MA

22h•$160,800 - $201,000•Hybrid

About The Position

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 feasibility and study start-up across all clinical programs. We 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 impact our clinical programs. The candidate will drive study start-up activities and be responsible for oversight of timelines and goals with respect to our clinical studies. This is a highly cross-functional position, requiring collaboration 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 Patient’s First.

Requirements

BA/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
Experience in clinical study budget planning, and program implementation
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 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
Candidates must be authorized to work in the U.S.

Nice To Haves

Experience with rare disease / difficult to recruit populations a plus

Responsibilities

Develop and implement feasibility and start-up strategies to support the success of Sarepta’s clinical studies.
Oversee study feasibility activities, including country, site, and investigator selection for participation in Sarepta clinical studies.
Gather cross-functional, country-level input to inform robust feasibility strategies.
Develop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.
Establish study-specific meetings to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO; report metrics to broader teams, including senior management.
Lead calls with Sarepta and CRO partners to manage feasibility and study start-up activities and ensure study timelines are achieved.
Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
Provide guidance and mentorship to junior members of the Study Start-up and Feasibility team.
Create reporting tools to measure ongoing activities, as well as key performance, quality, and effectiveness indicators.
Partner with Clinical Operations, CRO teams, and other key stakeholders to implement innovative feasibility initiatives, including data collection within CTMS.
Support and/or lead the development of charters and SOPs related to Study Start-up and Feasibility.
May have direct reports.