Lyell Immunopharma · 4 days ago
Senior Director, Clinical Development- Cell Therapy
South San Francisco, CA
Full-time
Onsite
Director/Executive
$300K/yr - $350K/yr
8+ years expLyell Immunopharma is a clinical-stage company focused on advancing next-generation CAR T-cell therapies for patients with solid tumors and hematologic malignancies. The Sr. Director, Clinical Development will provide clinical leadership and strategic direction for cell therapy programs, overseeing clinical trials and ensuring compliance with regulatory standards.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
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
Preferred
M.D. or M.D./PhD; current/prior board certification in oncology, hematology, or a related field is preferred
8+ years of related 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
Benefits
Subsidized medical, dental and vision plans from your first day of employment
FSA
Company provided Life and AD&D Insurance
STD and LTD Insurance
ESPP
401(k) Plan with Company match
Mass transit commuter benefits
Cell phone reimbursement
Flex Time off
Sick leave
8 observed holidays
Floating holiday
Winter office shutdown
Company
Lyell Immunopharma
Lyell Immunopharma is an operator of a biotechnology company that develops cellular therapies to cure cancer.
201-500 employees
H1B Sponsorship
Lyell Immunopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (5)
2021 (2)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$543M2025-07-25Post Ipo Equity· $50M
2021-06-16IPO
2020-03-12Series C· $493M
Leadership Team
Lynn Seely
President & Chief Executive Officer
Gary Lee
Chief Scientific Officer
Recent News
2025-12-25
2025-12-19
2025-12-09
Company data provided by crunchbase