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 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.

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 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).

PREFERRED EDUCATION:

• 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

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
• 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   Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our