Associate Medical Director / Medical Director, Oncology
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome).
Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
Building on the success of the ROSELLA phase 3 clinical trial, the Corcept Oncology Clinical Development Team is growing. The Associate Medical Director / Medical Director, Oncology will act as a key participant in building molecule and / or program strategy. They will ensure the good clinical conduct and scientific integrity of oncology clinical trials.
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 environmentAbility to establish and maintain a team sense of urgency around timelinesPreferred Education and Experience :
MD requiredBoard eligible or certified in an internal medicine subspecialty required; oncology / hematology board certification / eligibility preferred2+ years' clinical development experience in the biotechnology / pharmaceutical industry or an academic clinical trial unitA proven track record of scholarly clinical research demonstrated by publications in top tier journalsThe pay range that the Company reasonably expects to pay for this headquarters-based position is $240,000- $310,000; 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.