Associate Medical Director/Medical Director, Oncology

Role Summary

The Associate Medical Director/Medical Director, Oncology will act as a key participant in building molecule and/or program strategy and will ensure the good clinical conduct and scientific integrity of oncology clinical trials within Corcept’s oncology portfolio.

Responsibilities

• Act as clinical expert for internal Company 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 issues related to the therapeutic field
• Provide medical oversight for Company operational staff, CROs and clinical trial sites in areas related to oncology programs
• Design the clinical development plan for indications relevant to assigned molecules/programs and support assessment of development plans through the cross-functional product core team
• Design, develop and implement clinical studies for the drug candidate from Phase I through Phase III
• Establish relationships with external experts in scientific oncology to facilitate scientific excellence in clinical trials research
• 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, publications and other documents
• Deliver timely and high-quality clinical data
• Provide medical oversight and safety monitoring for ongoing clinical trials including SAE reporting and service on the safety committee
• Participate in regulatory discussions and activities, including filing INDs, CTXs, NDAs/MAAs throughout development
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Other duties as assigned

Qualifications

• Required: MD; board eligible or certified in an internal medicine subspecialty; oncology/hematology board certification/eligibility preferred
• Required: 2+ years of clinical development experience in the biotechnology/pharmaceutical industry or academic clinical trial unit
• Required: proven track record of scholarly clinical research demonstrated by publications in top-tier journals
• Preferred: excellent communication and leadership skills with ability to interact in a busy cross-functional environment
• Preferred: ability to establish and maintain a sense of urgency around timelines

Skills

• Clinical leadership and strategic planning
• Medical oversight of multicenter oncology trials
• Regulatory submissions and cross-functional collaboration
• Scientific writing and protocol development

Education

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

Additional Requirements

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