Senior Medical Director, Oncology Clinical Development

Initial Therapeutics, Inc.; Brisbane (CA); On-site; USD 285,000 - 390,000; Full time

Job summary

The position reports to the Chief Medical Officer and requires collaboration with study teams, regulatory affairs, and translational science to drive high-quality studies and efficient regulatory submissions. Brisbane, CA onsite.

Qualifications

• MD/PhD/PharmD with 15+ years of drug development experience and at least 5 years in oncology trials.
• Experience in oncology first-in-human and proof-of-concept studies is preferred.
• Excellent interpersonal and communication skills.

Responsibilities

• Lead cross-functional clinical development teams and collaborate with global study teams.
• Develop the Global Development Plan with senior clinical development staff.
• Implement the Global Development Plan with strategic clinical science support.
• Lead in reviewing and authoring clinical protocols and regulatory documents for US and ex-US authorities.
• Oversee safety oversight of trials in collaboration with Medical Monitor and Safety teams.
• Coordinate external medical advisory committees and support regulatory filings.
• Support data management, DSMB/Safety oversight, and study material preparation.
• Up to 25% travel (US and international).

Skills

Executive leadership

Oncology clinical trials

Interpersonal communication

ICH GCP knowledge

Education

MD/PhD/PharmD

Job description

The position reports to the Chief Medical Officer and requires collaboration with study teams, regulatory affairs, and translational science to drive high-quality studies and efficient regulatory submissions. Brisbane, CA onsite.