We are dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit.

VP, Clinical Development

Vice PresidentVice PresidentFull TimeRemoteTeam 51-200Since 2019H1B No SponsorCompany Site LinkedIn

Location

California

Posted

45 days ago

Salary

$350K - $385K / year

Postgraduate Degree15 yrs expEnglish

Job Description

• Define and drive the clinical development strategy for assigned programs. • Translate scientific, translational, and clinical data into clear development plans, milestone decisions, and risk-benefit assessments. • Ensure alignment of clinical strategy with regulatory expectations, target product profiles, and long-term portfolio objectives. • Lead the design and oversight and registration-quality clinical trials, including endpoint selection, patient population strategy, and global development considerations. • Provide senior clinical oversight to ensure trials meet registration standards for quality, safety, and data integrity. • Partner with Biometrics and Regulatory Affairs to ensure clinical strategy supports statistical and regulatory requirements. • Provide ongoing medical oversight of clinical trials, including safety monitoring, emerging data review, and protocol amendments. • Partner closely with Clinical Operations on trial feasibility, site strategy, enrollment planning, and CRO oversight. • Review and interpret clinical data to guide program adjustments and development decisions. • Ensure clinical readiness for audits, inspections, and regulatory review. • Represent Clinical Development in health authority interactions. • Provide clinical leadership for briefing documents, responses to regulatory questions, and clinical components of submissions. • Engage with investigators, advisors, and external experts to support development strategy and trial execution. • Collaborate closely with Translational Medicine, Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, and CMC teams. • Provide clinical input into biomarker strategy, safety strategy, and future lifecycle planning.

Job Requirements

MD required
Board certification preferred.
15+ years of clinical development experience in biotechnology and/or pharmaceutical organizations.
Proven leadership of late-stage and registration-enabling clinical trials, including global studies.
Direct involvement in regulatory submissions (e.g., NDA, BLA, MAA) and health authority interactions.
Experience working in well-established pharmaceutical development environments and applying those practices in smaller or earlier-stage organizations.
Background in immunology, autoimmune disease, or cell therapy required.
Experience leading programs through key inflection points (e.g., EOP2, pivotal study initiation, registration readiness).
Strong strategic thinking with the ability to integrate clinical, regulatory, and scientific perspectives.
Deep understanding of global clinical development and registration pathways.
Sound clinical judgment and risk-benefit decision-making capability.
Clear and credible communicator with regulators, investigators, executives, and cross-functional teams.
Sets a high standard for clinical excellence, patient safety, and data integrity.
Operates effectively in ambiguity while driving disciplined execution.
Models transparency, collaboration, and patient-centric decision-making

Benefits

A beautiful facility
An entrepreneurial, highly collaborative, and innovative environment
Comprehensive benefits, including: Medical, Dental, and Vision
Group Life Insurance
Long Term Disability (LTD)
401(k) Retirement Plan
Employee Assistance Program (EAP)
Flexible Spending Account (FSA)
Paid Time Off (PTO)
Company paid holidays, including the year-end holiday week
Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.