THE COMPANY

Sarepta Therapeutics headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.

This role is a unique opportunity for an experienced Clinical Operations leader to join the company at a pivotal transition point in supporting current and future joint development partnerships. Initial responsibilities will focus on clinical operational due diligence for new compounds/alliances, in-licensing, and acquisition opportunities. S/he will work cross-functionally to assess clinical resourcing needs, develop financial forecasts, define transition plans, and identify key risks to move studies from a partner to Sarepta.

PRIMARY RESPONSIBILITIES

Co-Development Partnerships and Due Diligence

• Working closely with Business Development, evaluate incoming clinical collaboration proposals by providing operational input into due diligence activities for 3rd party/partner clinical development programs for assets that may be incorporated into the Sarepta portfolio

• Identify risks and need for risk mitigation strategies

• Review and assess clinical development timelines and budgets

• Establish strong clinical partnership interfaces with existing and new collaborations to ensure execution and overall quality of clinical operations in External Collaborations and related relationships

• As a member of Clinical Development Operations leadership team, participate in internal cross-functional Assett Team and lead Development Teams where applicable, and act as point of contact for integration with corporate processes (e.g. BD, IR, Finance)

• Ensure clinical program activities and tactical execution are linked to program strategy

• Input into the development of clinical trial protocols, clinical development plans and associated documents for clinical studies that fall under the co-development model

• Evaluate resourcing needs and provide recommendations

• Design and guide implementation of plans to transition studies from partners to Sarepta

• Hire, train, supervise, and coach other clinical development operations staff

Clinical Program Lead for Medical Affairs Studies

• PROVIDE CLINICAL OPERATIONS EXPERTISE AND STRATEGIC INPUT FOR THE DEVELOPMENT OF PLANS TO SUPPORT MEDICAL AFFAIRS CLINICAL TRIALS

• Selection and oversight of clinical vendors including CROs

• Provide line management and program-level direction to clinical operations staff and support to ensure operational excellence in delivery of all clinical trials.

EDUCATION AND SKILLS REQUIREMENTS

• Bachelor’s Degree in life sciences with minimum of 15 years of pharmaceutical or biotechnology industry experience.
• MBA, Masters or advanced degree preferred
• Thorough knowledge and understanding of drug development and the clinical trial process.
• Experience with business development and due diligence processes
• Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
• Experience in developing strategy, especially related to clinical development plans and studies
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Independently motivated, detail oriented, and good problem-solving ability
• Excellent analytical and organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
• Excellent communications skills and ability to influence across multiple functions.

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.

Required Skills Required Experience

• Install, configure and maintain the AFRL organization's operating systems.
• Analyze and resolve problems associated with server hardware UNIX, applications software.
• Detect, diagnose, and report UNIX related problems on servers.
• Install new software releases, system upgrades, evaluates and installs patches and resolves software related problems for all UNIX based systems.
• Perform system backups and recovery.
• Maintain data files and monitors system configuration to ensure data integrity.
• Support recommendation of upgrades, patches, and new applications and equipment.
• Provide systems-level support, encompassing both the software and hardware of all IT systems at covered AFRL Wright-Patterson AFB to include maintenance of all software in use by AFRL organizations.
• Manage and arrange for or conduct maintenance on hardware in use by AFRL organizations.
• Perform management and support of deployed operating systems (Unix, and Linux), including performance of: upgrades, security patches, back-ups, account maintenance, and access control maintenance.
• Install, configure, update and assist users with scientific applications located on the computational resources.
• Provide support of multi-user platforms and server based applications by managing and administering directorate web-based services, assisting client users in connecting and using the centralized resources, performing backup and maintenance of the index and content database, clearing and maintenance of the system cache, and optimizing the server functions, creating content workspaces, managing document and folder areas, applying and assigning permissions.
• Conduct analyses, developing solutions, planning and coordinating tasks, maximizing overall system efficiency, providing for seamless integration or migration, and optimizing usability and effectiveness.
• Monitor and review technical activities to ensure compatibility with the objectives, plans, and Concept of Operations (CONOPS) of all AFRL organizations.
• Investigate hardware, software, and communications compatibility issues including analysis of development, test, and implementation plans, as well as formulating best practices for carrying out technical and developmental activities.
• Keep organizational IT managers apprised of state-of-the-art technologies, including state-of-the-art IT concepts, identifying potential benefits to the R&D or operational missions of the Directorate.
• Analyze scalability of software, systems, and networks.
• Participate in review and response for AFRL strategic investment in IT assets, to include analysis of purchase versus lease considerations, providing cost-benefit, and trade-off options.
• Research on-going as well as planned technical and development initiatives from within the Government, which impact overall architectural or design methodologies and concepts.
• Support activities related to the configuration management process. Adhere to Government prescribed procedures for notification and delivery of periodic releases and upgrades to the Government Configuration Control Manager (CM).
• Support and participate in research of on-going as well as planned technical and development initiatives from within the Government, that impact overall architectural or design methodologies and concepts.
• Support management and arrangement for hardware and software maintenance services on all AFRL-owned computer-communications systems equipment within AFRL organizations.
• Support migrations across development, test and production environments for all web based materials while maintaining configuration control of each of these environments.
• Support AFRL efforts for strategic investment in IT assets, to include analysis of purchase versus lease considerations, providing cost-benefit, and trade-off options, scalability of software, systems, and networks.
• Support performance of duties related to the tracking and management of IT software, equipment and assets, as designated by the Directorate. This includes, procurement, receiving, storage, inventory, tagging/identifying, moving and turn in. Support annual validations of software inventories and equipment accounts and support any required Report of Surveys for missing equipment following all applicable Directorate, Air Force and DoD instructions, policies and guidelines.
• Support tracking and delivery of CDRLs related to this function.
• Support collection of metrics data measures of responsiveness, completeness, and effectiveness of the service, and report data to stakeholders. Maintain the records for a minimum period of 1 year to ensure a statistically acceptable sampling in terms of both the current and cumulative quality of performance.
• Support preparation and management, and support arrange or conduct of IT related training for Government personnel and supporting contractors.
• Support Information Assurance/Cybersecurity programs carried out in full compliance with relevant Federal, DoD, AF, AFMC, Base, and Organizational regulations, instructions, and procedures.