Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat solid tumors, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
POSITION SUMMARY:
The incumbent will lead the clinical development strategy for a Program as well as manage trial strategy and execution across the Clinical Development Team. This role closely partners with Clinical Operations to collaborate with cross-functional teams internally and externally to ensure the successful development and approval of new therapies. This role can be based in South San Francisco, CA or Seattle, WA.
ROLES AND RESPONSIBILITIES:
- Develop and implement the clinical development strategy for a Program aligned with the company’s overall goals and objectives.
- Oversee development of clinical development plans (CDPs) and clinical trial protocols.
- Analyze and interpret clinical trial data including patient data, provide medical direction to teams for execution of protocols, to develop clinical study reports, and in making decisions and/or troubleshooting issues.
- Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials and develop and implement risk management strategies.
- Ensure the scientific integrity of clinical studies and compliance with regulatory requirements.
- Collaborate with regulatory affairs to define the regulatory strategy and provide oversight and expertise in the regulatory submission process (IND, BLA, etc.).
- Ensure adherence to all regulatory guidelines and Good Clinical Practice (GCP) standards.
- Lead and manage the clinical development team, provide guidance, mentorship, and professional development opportunities.
- Represent clinical development in executive leadership meetings and contribute to strategic decision-making processes.
- Serve as a medical representative in meetings with regulatory agencies (e.g., FDA, EMA).
- Develop and review scientific content for regulatory documents, scientific communications and marketing materials.
- Provide medical expertise to support product development, marketing, and sales teams.
- Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs).
PREFERRED EDUCATION:
- MD with 12 years’ experience; MD/PhD a plus; focus in oncology
- Medically licensed, Fellowship and/or Board certification in oncology, hematology
PREFERRED EXPERIENCE:
- A minimum of 10 years’ experience in clinical development, with substantial experience in the pharmaceutical industry leading successful clinical programs
- Proven experience in Phase 1 clinical programs
KNOWLEDGE, SKILLS AND ABILITIES:
- In-depth knowledge of clinical trial design, execution, and regulatory requirements.
- Demonstratable exceptional strategic thinking and problem-solving skills
- Excellent leadership and team management abilities
- Strong communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels
- Ability to manage multiple priorities in a fast-paced, dynamic environment
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.
Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found here.
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.