The VP of Clinical Development will plan, implement and direct the daily operation of clinical stage drug development projects for the company. Collaboration with key internal and external stakeholders will be key to support company initiatives that improve the quality and content of all clinical programs to achieve our strategic goals.
KEY ROLE AND RESPONSIBILITIES:
- Establish clinical development plans (clinical strategy) 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, prepare, and review study protocols and other required documentation in compliance with GCP and good medical practice.
- Provide clinical and scientific input during the development, execution and completion of clinical trials. Interpret clinical trial data, prepare clinical study reports, regulatory submission and publications based on the results.
- Lead development of clinical study documents to be used in regulatory interactions and filings and serve as medical representative with regulatory agencies
- Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies to inform clinical strategy
- Manage the safety monitoring of clinical trials and prepare safety reports
- Present and defend clinical development plans/designs at internal governance forums
- Prepare and review investigator brochure and annual reports
- Guide partnered development programs and clinical protocols using Lyell technology
- Stay abreast with external competitions and treatment landscape
- Participate in or lead the clinical advisory board meetings to obtain strategic insights for clinical development plan
- MD with a minimum of 5 years’ experience; Medically licensed, Fellowship and/or Board certification in oncology
- PhD in immunology, oncology or related field strongly recommended
- 3+ years as a Medical Director in the biotech or pharmaceutical industry
- Clinical Oncology experience with a focus on solid tumors
- Early and late phase clinical trial experience
- Pre-IND and IND submissions
KNOWLEDGE, SKILLS AND ABILITIES:
- Strong team interaction and communication skills
- Strong leadership presence and the ability to work effectively with other clinical and scientific leaders.
- A passion for helping patients with cancer and for the science of oncology
- Collaborative style with internal company leadership, external development partners and investigators/medical professionals
- Works well in a team environment both as a leader and a key contributor
- Troubleshoots problems and comes up with solutions or options for discussion
Troubleshoots and solves complex technical problems within their own projects and within other areas of Research and Development. Identifies issues and communicates them to the group independently. Contributes significantly to functional strategy.
Decisions typically impact a function although may have cross-organization influence. Decisions are guided by policies, procedures and function objectives. Makes decisions about the direction of the project, experimental direction, modifications and analysis independently. Can decide to integrate new types of analysis to improve data through collaborations. Decisions can impact analysis and timelines.
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.