Associate Medical Director/Medical Director, Oncology

Role Summary

Associate Medical Director/Medical Director, Oncology. Build molecule and/or program strategy and ensure good clinical conduct and scientific integrity of oncology clinical trials within Corcept's Oncology Clinical Development Team.

Responsibilities

• Act as clinical expert for internal team members and external contacts related to the assigned therapeutic programs
• Provide clinical and scientific leadership, including training and ongoing input, to members of the Development and product Core Teams
• Provide medical oversight for operational staff, CROs and clinical trial sites in oncology programs
• Design the clinical development plan for indications relevant to assigned molecules and support assessment of development plans through the cross-functional product core team
• Design, develop and implement clinical studies from Phase I through Phase III
• Establish relationships with external experts in scientific oncology areas 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 review of 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 safety committee participation
• Participate in regulatory discussions and activities, including filing INDs, CTXs, NDA/MAAs throughout development
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Other duties as assigned

Qualifications

• MD required; board eligible or certified in an internal medicine subspecialty; oncology/hematology board certification/eligibility preferred
• 2+ years‚Äô clinical development experience in the biotechnology/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 with ability to interact in a busy cross-functional environment

Skills

• Clinical development leadership
• Medical oversight and safety monitoring
• Regulatory submissions and cross-functional collaboration
• Strategic clinical development planning
• Relationship building with external experts and investigators

Education

• MD required

Additional Requirements

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