Building on the success of our Phase 3 ROSELLA clinical trial, Corcept's Oncology Clinical Development team is entering an exciting period of growth. We are seeking a Medical Director, Oncology to play a pivotal role in shaping clinical development strategy and advancing innovative oncology programs from early development through late-stage trials. This is an opportunity to bring your scientific and clinical expertise to a growing pipeline, collaborate with leading investigators and cross-functional teams, and help translate promising science into meaningful new treatment options for patients.
Responsibilities:- Act as clinical expert for both internal Company team members and for 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 on issues related to the therapeutic field
- Provide medical oversight for Company operational staff, CROs and clinical trial sites in areas related to the oncology programs
- Design the clinical development plan for indications relevant to assigned molecules programs and support the assessment of the development plans through the cross-functional product core team
- Design, develop and implement clinical studies for the applicable drug candidate, from Phase I through Phase III
- Establish relationships with external experts in the scientific oncology areas, including principal investigators and opinion leaders, to facilitate scientific excellence in clinical trials research
- Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
- Participate in the 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 participation in SAE reporting and serving on the safety committee
- Participate in appropriate regulatory discussion and activities, including the filing of IND's, CTXs, NDA/MAAs, throughout the development cycle
- Participate in clinical study report conceptualization, development and writing for global regulatory submissions
- Other duties as assigned
Preferred Skills, Qualifications and Technical Proficiencies:- Candidates must be excellent communicators with proven leadership skills and the ability to successfully interact in a busy cross functional environment
- Ability to establish and maintain a team "sense of urgency" around timelines
Preferred Education and Experience:- MD required
- Board eligible or certified in an internal medicine subspecialty required; oncology/hematology board certification/eligibility preferred
- 2+ years' clinical development experience in the biotechnology/pharmaceutical industry or an academic clinical trial unit
- A proven track record of scholarly clinical research demonstrated by publications in top tier journals
The pay range that the Company reasonably expects to pay for this headquarters-based position is $261,400 - $307,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
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