Medical Director - San Diego, United States - OBI Pharma USA

Description

Job Title:
Medical Director (or Senior Medical Director)


General Statement:

In conjunction with the Chief Medical Officer and Product Development leaders and in collaboration with scientific, clinical, and project teams of the company, the Medical Director will primarily build and strategize oncology clinical product development (including the Clinical Development Plan) for new OBI products.

The Director will collaborate with team members to strategize the preparation, review and execution of clinical study documents, guide the evaluation of emerging clinical trial data including pharmacology, ensure that assigned studies are conducted according to GCPs and Departmental SOPs; review Pharmacovigilance events as needed; oversee/guide clinical data publishing and dissemination, and lead the clinical preparation of IND/NDA/BLA filing packages.

Reports to:

CMO

Primary Duties and Responsibilities, including mental requirements of the position:

• Designs and optimizes oncology clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts, and clinical study reports in collaboration with the clinical development team.
• Interfaces and leads interactions with investigators, academicians, and thought leaders via a variety of interaction settings including academic society meetings, advisory boards, and investigator meetings.
• Serves as a medical monitor as needed, including evaluation of safety, pharmacology, and efficacy in ongoing and completed studies in close collaboration with clinical scientists and the Safety and Clinical Operations teams.
• Works on regulatory submission documents including INDs.
• Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with preclinical scientists, consultants, and collaborators.
• Supports Business Development by evaluating new product potential.
• Manages a medical and translational team of limited size.
• Other duties as assigned.

Experience, education, or skills required of the incumbent in this position:

• M.D. or D.O. degree, preferably with board certification in Medical Oncology.
• 3+ years of industry experience in the design and management of clinical studies for Medical Director or 5+ years for Senior Director preferred.
• Demonstrated understanding of the drug development process, including experience with Clinical Development Plans, authorship of clinical protocols/investigator brochures, regulatory strategy, basic drug manufacturing and supply chain, and budgeting.
• Strong knowledge of Good Clinical Practices, FDA regulations, and guidelines and applicable regulatory requirements.
• Participation in authorship of elements of a clinical study report in industry preferred.
• IND/BLA experience a plus.
• Strong interpersonal skills and the ability to communicate effectively with coworkers, senior management, investigators, and key opinion leaders in diverse settings.
• Strong verbal presentation and technical writing skills.
• Ability to effectively obtain and evaluate outside expert advice.
• Ability to work independently, as well as effectively lead and participate on teams.
• Possesses a strong sense of urgency; proactively identifies challenges and problems and rapidly proposes solutions.

Pay:
$250, $330,000.00 per year


Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Doctorate (required)

Experience:

- design and management of clinical studies in industry: 3 years (preferred)

Work Location:
Hybrid remote in San Diego, CA 92121