Sr. Director, Corporate Counsel, Clinical Research

Sarepta Therapeutics•Cambridge, MA

1d•Hybrid

About The Position

The Sr. Director, Corporate Counsel, Clinical Research position at Sarepta Therapeutics is a strategic role supporting the company’s global clinical development operations. This role involves managing legal aspects of clinical research, including risk/benefit analyses, regulatory compliance, data privacy, inspection readiness, and vendor management. The position requires drafting, reviewing, and negotiating clinical-related agreements, supervising direct reports and outside counsel, and partnering with regulatory legal counsel and the compliance team. Success in this role depends on the ability to assess legal and business risks, communicate recommendations clearly to senior executives, advise on acceptable risk levels, and develop innovative solutions to complex issues. The role demands independent work with stakeholders across the company, managing competing demands in a fast-paced, mission-driven environment, and strong management, negotiation, communication, and interpersonal skills.

Requirements

Juris Doctor from an accredited national law school; admitted to at least one state bar in good standing.
13+ years of experience drafting and negotiating clinical-related contracts and advising on clinical-related legal matters.
Excellent management, drafting, negotiation, and communication skills (both verbal and written).
Working knowledge of relevant national and international laws and regulations and ability to interpret and apply the same to inform business activities.
Demonstration of intellectual and emotional intelligence and maturity combined with a team-oriented approach.
A demonstrated ability to collaborate, as well as to work independently, balancing competing priorities in a fast-paced, deadline-driven environment with professionalism.
Detail-oriented.
Ability to handle confidential and proprietary information using excellent discretion and judgment.
Self-motivated, able to work independently and be reliable and responsive.
Ability to be flexible and willing to accept new responsibilities, as needed.
Candidates must be authorized to work in the U.S.

Nice To Haves

Ideally, in-house experience as a member of a legal department in a biotechnology or pharmaceuticals company, clinical affairs department, or contract research organization.

Responsibilities

Draft, negotiate, and manage a high volume and wide variety of domestic and international clinical-related documents, including informed consent forms, clinical trial agreements, investigator-initiated agreements, clinical data privacy and use agreements, contract research organization agreements, clinical master service agreements, consulting agreements, and other contracts related to the clinical development of therapeutic products.
Provide practical, actionable and timely legal advice and support to internal clinical operations teams on domestic and international clinical-related legal matters, including analyzing and providing advice with respect to interpretation of existing agreements, risk/benefit assessment, and clinical regulatory compliance.
Coordinate and assist in developing and implementing policies, procedures, and systems, as well as developing a library of templates to support and facilitate efficient clinical contract development and analyses.
Generate reports, presentations, spreadsheets, memoranda, and other documents for the senior management team, as requested; be comfortable presenting same in management meetings.
Evaluate and advise on high stake matters presented in the context of FDA inspections of clinical investigations.
Monitor and report on the legal environment and trends concerning clinical development.
Supervise direct reports in work related to the above responsibilities.
Serve as a liaison with and provide oversight of outside counsel.
Partner closely with the company’s regulatory legal counsel and compliance team.