Clinical & Regulatory
Seattle, Washington, United States
09/30/22

Medical Director

At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
 

POSITION SUMMARY:

The incumbent will own the planning, implementation and daily operation of drug development projects for the company. This role will collaborate with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to achieve our strategic goals.

KEY ROLE AND RESPONSIBILITIES:

  • Provide medical oversite of clinical trials
  • Work effectively to collaborate with multifunctional team including but not limited to safety science, medical writing, translational science, biostatistics, data management, and clinical operations.
  • Provide protocol specific training to sites and internal personal.
  • Provide subject matter expertise to the development of documents to include but not limited to protocols or protocol amendments, investigator brochures, and briefing books for regulatory interactions.
  • Evaluate safety and efficacy data and assist with interpretation
  • Participate in ongoing data review and data cleaning to support ongoing clinical trials.
  • Maintain background disease specific knowledge relevant to ongoing and planned clinical trials.
  • Develop and maintain knowledge of competitive therapeutic landscape
  • Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development
  • Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan
  • Present and defend protocols and clinical development plans at internal governance forums
  • Lead development of clinical study documents to be used in regulatory interactions and filings
  • Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies to inform clinical strategy
  • Manage the safety monitoring of clinical trials and studies
  • Prepare clinical protocol and review investigator brochure

PREFERRED EDUCATION:

  • MD with a minimum of 15 years’ experience; or
  • Medically licensed, Fellowship and/or Board certified

 PREFERRED EXPERIENCE:

  • A minimum of 3 years of relevant experience as a Medical Director in the biotech or pharmaceutical industry
  • Clinical Oncology experience with a focus on solid tumors
  • Experience with cellular therapy clinical trials
  • Early and late phase clinical trial experience

 KNOWLEDGE, SKILLS AND ABILITIES:

  • Proven ability to work in a startup environment
  • Strong team interaction and communication skills
  • Demonstrated strong leadership presence and the ability to work effectively with other clinical and scientific leaders
  • Demonstrate a passion for helping patients with cancer and for the science of oncology
  • Recognized collaborative style with internal company leadership, external development partners and investigators/medical professionals
  • Demonstrated ability to operate as a team player, working well in a team environment both as a leader and a key contributor
 
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.
 
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine.  The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
 
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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