Vice President, Clinical Development jobs in United States
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Lyell Immunopharma · 18 hours ago

Vice President, Clinical Development

Lyell Immunopharma is a clinical-stage company focused on advancing next-generation CAR T-cell therapies for cancer treatment. The Vice President of Clinical Development will lead the clinical development strategy and manage trial execution while collaborating with cross-functional teams to ensure successful therapy development and approval.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

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 ans (CDPs) and clinical trial
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
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)
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
Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs)

Qualification

Clinical development strategyOncology expertiseClinical trial designRegulatory complianceLeadership abilitiesStrategic thinkingProblem-solving skillsCommunication skillsInterpersonal skillsTeam management

Required

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
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
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)
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
Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs)
In-depth knowledge of clinical trial design, execution, and regulatory
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

Preferred

MD with a minimum of 15 years' experience with a focus in oncology; or
MD/PhD with a minimum of 12 years' experience with a focus in oncology
Medically licensed, Fellowship and/or Board certification in oncology, hematology
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

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
A 401(k) Plan with Company match
Mass transit commuter benefits
Cell phone reimbursement
Flex Time off
Sick leave
8 observed holidays
A floating holiday
Winter office shutdown

Company

Lyell Immunopharma

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Lyell Immunopharma is an operator of a biotechnology company that develops cellular therapies to cure cancer.

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 Company
Total Funding
$543M
2025-07-25Post Ipo Equity· $50M
2021-06-16IPO
2020-03-12Series C· $493M

Leadership Team

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Lynn Seely
President & Chief Executive Officer
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Gary Lee
Chief Scientific Officer
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Company data provided by crunchbase