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
- MD with a minimum of 15 years’ experience; or
- Medically licensed, Fellowship and/or Board certified
- 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
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 employees and their dependents.
The salary range for this position is $210,000 to $235,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
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 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits can be found on our website.
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.