Description:

About the Position:
Reporting to the General Counsel, the Senior Director, Assistant General Counsel will serve as a trusted legal advisor and strategic business partner to Clinical Operations, Medical Affairs, Research, Commercial and Manufacturing and other cross-functional stakeholders, enabling efficient decision-making while appropriately managing legal and compliance risk. The Senior Director, Assistant General Counsel brings a strong background in life sciences or biotechnology, with a demonstrated ability to navigate complex legal issues in a fast-paced and collaborative environment.

Responsibilities include:

Translate complex legal and regulatory requirements into practical, business-oriented advice for internal stakeholders.
Proactively support a broad range of functions within the Company, with a primary focus on Clinical Operations, Medical Affairs, Research, and Commercial.
Draft, review, and negotiate a wide variety of agreements, including clinical trial agreements and related informed consent forms and protocols, research and development agreements, manufacturing and supply agreements, consulting agreements, service agreements, and material transfer agreements for activities in the U.S., Canada, EU, and UK.
Provide legal support for commercial activities ahead of commercial launch, including serving as a reviewer on promotional review committees and advising on compliance matters related to HCP engagements, speaker programs, advisory boards, grants, charitable contributions, sponsorships, consultant arrangements, and interactions with healthcare organizations.
Advise on U.S. privacy and EU/UK GDPR issues as they relate to clinical trial participant, patient, and employee data.
Collaborate with cross-functional teams to ensure regulatory compliance across relevant aspects of the business, including clinical trials, FDA regulations, GCP requirements, and healthcare compliance.
Support the development of Company policies, promote ethical practices, and support the implementation of the compliance program throughout the organization.

Required Qualifications:

Juris Doctor degree with 8+ years of general corporate legal experience in the biotechnology and/or pharmaceutical industries in either an in-house, private practice, or combined setting.
3+ years of practice with an established law firm preferred.
Demonstrated ability to provide pragmatic, risk-based legal guidance in support of business objectives.
Strategic thinker who translates complex legal and regulatory requirements into practical business guidance.
Strong team orientation with a demonstrated ability to build strong relationships across various business functions and a passion for continuous self-development.
Ability to manage multiple complex tasks while maintaining focus on critical priorities.
Outstanding integrity and ethical conduct.
Solid understanding of the legal issues affecting the pharmaceutical industry, with a particular focus on clinical development, medical affairs activities, research collaborations, regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption, and antitrust laws.

Preferred: