The incumbent is responsible for the provision of legal support and counsel to Clinical and Regulatory Operations, with an emphasis on drafting, negotiating, executing and managing contracts with industry sponsors, government agencies, universities and healthcare companies. This role sits within the corporate legal team and will be required to support transactional needs in other parts of the business, including Business Development, Technical Operations and various contract support organizations.
KEY ROLE AND RESPONSIBILITIES:
- Drafting and negotiating agreements including collaboration, informed consent forms, confidentiality, regulatory, consulting, supply, investigator initiated/sponsored studies, CRO contracting, research, and other related clinical trial agreements
- Leading the continuous improvement of law department operations through problem solving, strategic planning, project management, process, and systems improvement, and financial/budget management
- Assisting with development of law department policies and procedures relating to law department activities
- Providing guidance on regulatory matters and assisting with development and implementation of compliance strategies
- Assists with other law department matters, including litigation support, corporate governance, permitting, intellectual property records management, due diligence, employment, immigration, facilities, leasing, construction, and security as required
- Managing the use of outside counsel for transactions and determining which outside counsel to use taking into account cost, speed of review and technical expertise
- BA/BSc and JD from an accredited law school with a minimum of 10 years’ experience
- Minimum of 5 years of management-level clinical and regulatory contracts experience in a major law firm, pharmaceutical, biotechnology or CRO
- Prior experience in representing publicly traded biotechnology or pharmaceutical companies
- In-house experience at a publicly traded biotech/pharma company
- Experience drafting and negotiating Clinical Trial Agreements in, or on behalf of, a life sciences organization with industry sponsors, government agencies, universities and large healthcare companies
- Experience drafting and negotiating agreements including collaboration, informed consent forms, confidentiality, regulatory, consulting, supply, investigator initiated/sponsored studies, CRO contracting, research, and other related clinical trial agreements
KNOWLEDGE, SKILLS AND ABILITIES:
- Knowledge of current laws, regulations and industry standards governing clinical trials, such as FDA regulations, ICH Guidelines, and GCPs
- Proven executive presence and ability to interact comfortably with executives and senior management
- Demonstrated ability to thrive in a fast-paced and unstructured environment; sense of urgency in responding to time-sensitive matters; and the ability to manage several simultaneous projects under deadline pressure
- Proven ability to work efficiently both independently and in cross-functional teams, multitask with ease, and skillfully manage internal and external stakeholders
- Proficient with software programs and computer applications, including Microsoft Office, Google Docs, Slack, Box, etc.
- Strong verbal/written communication and analytical skills with an understanding of scientific/technical information and terminology
- Demonstrated strong interpersonal skills with the ability to take on various projects as assigned
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.