Associate Medical Director/Medical Director, Oncology

Role Summary

Associate Medical Director/Medical Director, Oncology. Lead molecule/program strategy and ensure good clinical conduct and scientific integrity of oncology clinical trials within Corcept’s oncology development efforts.

Responsibilities

• Act as clinical expert for internal teams and external contacts related to assigned therapeutic programs
• Provide clinical and scientific leadership, including training and ongoing input, to Development and product Core Teams on therapeutic field issues
• Provide medical oversight for operational staff, CROs and clinical trial sites related to oncology programs
• Design the clinical development plan for indications relevant to assigned molecules and support assessment through the cross-functional product core team
• Design, develop and implement clinical studies from Phase I through Phase III
• Establish relationships with external oncology experts to facilitate scientific excellence in trials
• Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports
• Participate in writing and reviewing clinical protocols, investigator brochures, clinical study reports and publications
• Deliver timely and high-quality clinical data
• Provide medical oversight and safety monitoring for ongoing trials, including SAE reporting and safety committee participation
• Participate in regulatory discussions/activities, including filing INDs, CTXs, and NDA/MAAs
• Participate in CSR conceptualization, development and writing for global regulatory submissions
• Other duties as assigned

Qualifications

• MD required; board eligible or certified in internal medicine subspecialty; oncology/hematology board certification/eligibility preferred
• 2+ years of clinical development experience in biotech/pharmaceutical industry or academic clinical trial unit
• Proven track record of scholarly clinical research demonstrated by publications in top-tier journals
• Excellent communication and leadership skills; ability to work in a busy cross-functional environment
• Ability to establish and maintain a sense of urgency around timelines

Skills

• Clinical leadership
• Medical oversight and safety monitoring
• Study design and clinical development planning
• Regulatory Affairs understanding (INDs, CTXs, NDA/MAAs)
• Scientific writing and collaboration with investigators and opinion leaders

Education

• MD required
• Board eligible or certified in internal medicine subspecialty; oncology/hematology certification/eligibility preferred

Additional Requirements

• Applicants must be authorized to work in the United States on a full-time basis