Sr/Exec Director Clinical Development

Overview

In this leadership position, you will drive the clinical aspects of late-stage development programs, focusing on pivotal trials that lead to regulatory approval and commercial launch. Reporting directly to the Chief Medical Officer, you will serve as a key architect of the Clinical Development Plan, ensuring that medical and scientific trial issues are addressed with innovative and efficient solutions while maintaining individual study-level responsibility for critical oncology trials.

Responsibilities

• Lead the strategic planning and execution of clinical studies to advance programs through pivotal trials and regulatory submissions.
• Develop essential clinical documents including INDs, protocols, Investigator Brochures, and applicable regulatory filings.
• Collaborate with cross-functional teams to provide medical and scientific input for study activation and data review processes.
• Represent the organization externally at scientific congresses and meetings with global health authorities.
• Analyze and interpret complex clinical data to provide strategic insights that inform critical program development decisions.
• Manage clinical development timelines and resource allocation to ensure the successful achievement of program milestones.
• Establish and maintain professional relationships with clinical investigators, regulatory agencies, and internal stakeholders.

Qualifications

• You must hold at least an undergraduate degree in a health science field, with a PhD or PharmD highly preferred.
• You need a minimum of 10 years of experience within the biotech or pharmaceutical industry as a clinical scientist.
• You must possess extensive experience managing oncology clinical trials, specifically in late-stage development settings.
• You are required to have experience working within dynamic startup or small company environments.
• You need deep technical knowledge of biostatistics, Good Clinical Practice, and regulatory requirements for clinical studies.
• You must demonstrate the ability to evaluate and present complex scientific data to diverse stakeholder groups.

Nice to have

• Experience leading clinical development contributions to major regulatory submissions such as NDAs or Breakthrough Therapy Designations is highly preferred.
• Prior exposure to early-stage clinical development is considered a plus for this strategic role.
• A proven track record of navigating accelerated review processes and label negotiations with health authorities is an advantage.

Work environment

• The role is based in San Diego, California, with remote-friendly work arrangements available.
• You will work in a fast-paced, mission-oriented startup environment that emphasizes collaboration and a can-do attitude.
• The position involves a standard 40-hour work week with the flexibility required to manage strategic shifts and deadlines.
• You will interact frequently with cross-functional teams and external scientific partners in a casual yet professional setting.

Benefits & growth

• The anticipated base salary range for this executive-level position is $265,000 to $310,000 per year.
• You are eligible for an annual performance bonus and equity grants in the form of stock options.
• The comprehensive benefits package includes medical, dental, and vision plans, plus an employer-contributed 401(k).
• Perks include pet insurance, flexible spending accounts, and participation in an Employee Stock Purchase Program.
• The role offers significant career growth through high-level visibility and leadership of programs aimed at eracing cancer.