Associate Director, Clinical and Regulatory Operations
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.
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
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
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.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.