Medical Director, Oncology
Corcept Therapeutics
Summary
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.
Job description
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
Requirements
- 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
- Excellent communicators with proven leadership skills
- Ability to successfully interact in a busy cross functional environment
- Ability to establish and maintain a team "sense of urgency" around timelines
Company overview
Corcept Therapeutics Inc. is a commercial-stage pharmaceutical company founded in 1998 and headquartered in Redwood City, California. The company specializes in the discovery, development, and commercialization of medications that treat severe metabolic, oncologic, and neuropsychiatric disorders by modulating the effects of the hormone cortisol. Corcept's primary focus is on addressing the adverse effects of excess cortisol, which can lead to life-threatening conditions including Cushing's syndrome, various cancers, diabetes, and neurological disorders. The company's flagship product is Korlym (mifepristone), the first FDA-approved oral therapy for treating hyperglycemia in adult patients with endogenous Cushing's syndrome who have type 2 diabetes or glucose intolerance. With approximately 500 employees, Corcept has developed a large portfolio of proprietary compounds that selectively modulate cortisol effects without compromising progesterone function. The company maintains extensive intellectual property covering its selective cortisol modulators and continues to advance clinical trials for potential treatments of hypercortisolism, advanced ovarian cancer, prostate cancer, ALS, and MASH.