Senior Director, Clinical Development- Cell Therapy
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. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. 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 advance next-generation CAR T-cell therapies, 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.
The Sr. Director, Clinical Development is a pivotal role within our organization, responsible for providing clinical leadership and strategic direction for one of our cutting-edge cell therapy programs, including those in pivotal stage development. This individual will play a crucial role in advancing our cell therapy initiative from early-phase research through to commercialization.
KEY ROLE AND RESPONSIBILITIES:
• Lead the design, implementation, and oversight of clinical trials for cell therapy products.
• Analyze and interpret clinical trial data and provide medical input for clinical study reports.
• Ensure the scientific integrity of clinical studies and compliance with regulatory requirements.
• Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs).
• 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.
• Collaborate with regulatory affairs to prepare and review regulatory submissions (IND, BLA, etc.).
• May develop and review scientific content for regulatory documents, scientific communications and marketing materials.
• Provide guidance and mentorship to members of the clinical development team; support professional development opportunities for team members.
• May represent clinical development in executive leadership meetings and contribute to strategic decision-making processes.
• Participate in cross-functional project teams and contribute to strategic planning.
• Provide medical expertise to support product development, marketing, and sales teams.
• Ensure adherence to all regulatory guidelines and Good Clinical Practice (GCP) standards.
• Substantially develop the Clinical Development Plan (CDP) and clinical trial protocols.
PREFERRED EDUCATION:
• M.D. or M.D./PhD; current/prior board certification in oncology, hematology, or a related field is preferred.
• 8+ years of related experience
PREFERRED EXPERIENCE:
• Minimum of 5 years of clinical research experience in oncology; experience with cell or immunotherapy is preferred.
• Demonstrated experience in the design, execution, and oversight of clinical trials.
• Experience with regulatory submissions and interactions with regulatory agencies is highly desirable.
KNOWLEDGE, SKILLS AND ABILITIES:
• In-depth knowledge of regulatory requirements and GCP standards.
• Strong analytical and problem-solving skills, with the ability to interpret complex clinical data.
• Excellent leadership and cross-functional collaboration/team leadership capability.
• 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
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 Flex Time off, sick leave, 8 observed holidays as well as a floating holiday. We also have a winter office shutdown.
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.
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.
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