Sr. Director, Corporate Counsel, Clinical Research

Sarepta Therapeutics•Cambridge, MA

1d•Hybrid

About The Position

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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

The promise of genetic medicine has arrived, and Sarepta is at the forefront.
We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases.
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.
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
Seeking a strategic, experienced attorney to support the company’s global clinical development operations, including risk/benefit analyses, clinical regulatory compliance, clinical data privacy and management, inspection readiness, and vendor and site issue management.
This position will be responsible for drafting, reviewing, and negotiating clinical-related agreements, forms and other documents, as well as supervising the work of direct reports and outside counsel with respect to the same.
This position will partner closely with the company’s regulatory legal counsel and compliance team.
To be successful in this role, you must have the ability to anticipate and assess legal and business risks associated with complex matters.
You should be able to clearly and concisely communicate well-reasoned recommendations to internal stakeholders, including senior executives.
In addition, you should be comfortable with calibrating and advising on acceptable levels of risk commensurate with broader business objectives.
You also will be expected to develop and recommend innovative solutions to complex legal and business issues.
You must be able to work closely and independently with stakeholders across the company.
You should feel comfortable managing competing objectives and demands from a variety of stakeholders in a high-paced, mission-driven environment.
Finally, you should possess strong management, negotiation, communication and interpersonal skills.
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.

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.