Location: Redwood City, CA
Position SummaryImmunEdge is seeking an accomplished physician leader to provide strategic and operational leadership for the clinical development of its portfolio of innovative therapeutics. This individual will be responsible for defining and executing clinical development strategies that translate compelling science into meaningful outcomes for patients.
The successful candidate will bring deep expertise in oncology and immune-oncology drug development, a strong understanding of translational science and biomarker driven development and demonstrated experience advancing novel therapeutics through clinical development and regulatory interactions.
This is a highly visible leadership position requiring both strategic perspective and hands on engagement. The individual will partner closely with Research, Translational Medicine, Clinical Operations, Regulatory Affairs, Biometrics, Pharmacovigilance, CMC, and executive leadership to establish development priorities and advance programs efficiently and rigorously.
Depending upon the final scope of the position, this role may be structured as Senior Vice President, Clinical Development or Chief Medical Officer.
Key ResponsibilitiesClinical Development Strategy - Define and lead the overall clinical development strategy for ImmunEdge programs, including indication selection, development sequencing, clinical positioning, and evidence generation strategy.
- Develop integrated clinical development plans from first in human studies through proof of concept, registrational development, and potential lifecycle expansion.
- Translate emerging scientific and translational findings into differentiated clinical development strategies.
- Provide leadership on patient selection, dose and schedule optimization, clinical endpoints, biomarkers, combination strategies, and benefit risk assessment.
- Continuously evaluate emerging clinical data, the competitive landscape, treatment standards, and scientific developments to inform program strategy and investment decisions.
Clinical Program Leadership - Provide medical and scientific leadership for the design, execution, analysis, and interpretation of clinical studies.
- Lead and oversee development of protocols, Investigator Brochures, clinical sections of regulatory submissions, clinical study reports, and other key development documents.
- Provide senior medical oversight of ongoing clinical trials, including review and interpretation of safety, efficacy, pharmacokinetic, pharmacodynamic, and biomarker data.
- Partner closely with Clinical Operations to ensure that development strategy is translated into executable studies with appropriate quality, speed, and scientific rigor.
- Chair or provide senior leadership to clinical development and program teams as appropriate.
Regulatory and Development Strategy - Partner closely with Regulatory Affairs to develop global regulatory strategies that support efficient advancement of ImmunEdge programs.
- Provide clinical and medical leadership for interactions with the FDA, EMA, and other global health authorities.
- Contribute to regulatory briefing packages, responses to health authority questions, development milestone meetings, and major regulatory submissions.
- Evaluate opportunities for accelerated and expedited development pathways where scientifically and clinically appropriate.
Safety and Benefit Risk - Provide senior medical leadership in the ongoing assessment of patient safety and benefit risk throughout development.
- Partner with Pharmacovigilance and other functional experts in the evaluation of emerging safety signals, risk mitigation strategies, safety governance, and regulatory safety communications.
- Ensure appropriate medical oversight and escalation of clinically significant findings.
External Scientific Leadership - Develop and maintain strong relationships with leading investigators, key opinion leaders, cooperative groups, scientific advisors, and other external experts.
- Represent ImmunEdge at major scientific and medical conferences, investigator meetings, advisory boards, and other external forums.
- Provide leadership in the interpretation and communication of clinical data through scientific presentations, publications, and other appropriate channels.
- Evaluate external clinical and scientific opportunities that may complement or strengthen the ImmunEdge portfolio.
Organizational and Executive Leadership - Serve as a senior development leader and strategic partner to the CEO and executive leadership team.
- Provide clear, data driven recommendations regarding clinical development priorities, program risks, resource requirements, and portfolio decisions.
- Build, lead, develop, and mentor a high performing clinical development organization appropriate to the stage and needs of the company.
- Establish fit for purpose clinical development capabilities, governance, processes, and external partnerships.
- Manage consultants, advisors, CRO relationships, and other external clinical resources as appropriate.
- Contribute to Board discussions, business development activities, diligence processes, partnering discussions, and investor or external stakeholder interactions as needed.
Qualifications:- MD or equivalent medical degree required.
- Board certification or advanced clinical training in Medical Oncology, Hematology Oncology, or a closely related specialty strongly preferred.
- Significant clinical development experience within biotechnology or pharmaceutical organizations, with progressively increasing leadership responsibility.
- Deep expertise in oncology and immuno-oncology drug development and demonstrated understanding of the evolving treatment landscape.
- Demonstrated experience designing and leading early-stage oncology clinical trials. Experience progressing programs into later stage or registrational development is strongly preferred.
- Experience with novel oncology or immune based therapeutic modalities and biomarker driven development strongly preferred.
- Experience with development of multi-specific antibodies preferred.
- Meaningful experience interacting directly with the FDA and other global regulatory authorities.
- Demonstrated ability to integrate clinical, translational, regulatory, safety, operational, and commercial considerations into development strategy.
- Strong record of building productive relationships with investigators and external scientific leaders.
- Experience leading and developing clinical development professionals and multidisciplinary teams.
- Excellent scientific judgment, communication skills, executive presence, and ability to operate effectively in a rapidly evolving biotechnology environment.
ImmunEdge offers a competitive employment package that includes an annual bonus plan, equity, and a generous benefits package including comprehensive health (medical, dental, and vision) insurance for our employees and their families, a 401k plan, FSA plans (medical, dependent), an Employee Assistance Plan, and a holiday and paid time off plan.
