Ardea, headquartered in San Diego, California, is a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.
The Medical Director participates in the development and implementation of the organization’s clinical development strategy for our gout franchise, for US and worldwide trials. Serves as an integral member for clinical development, providing medical leadership, perspective and expertise for Phase I-IV across all therapeutic areas.
Primary Duties and Responsibilities
- Participates in the design, execution and reporting of Company-sponsored worldwide clinical trials programs, including clinical trial strategy and plans, overall study design, protocol execution, and the identification of suitable investigators and consultants across all therapeutic areas, particularly Gout.
- Provides medical expertise ensuring the safety of the products and patients, including adverse event evaluation..
- Evaluate efficacy data; summarize data for other members of senior management or outside parties.
- Interfaces with regulatory agencies for clinical development programs and regulatory submissions as delegated.
- Provides medical perspective to the clinical development team.
- Oversees the interaction with medical consultants and some clinical advisors and investigators as delegated to influence and expedite the progression of studies.
- Participates in the preparation of protocols, investigative brochures, study reports, safety reports, and the clinical sections of the Annual Reports, INDs, NDAs, SOPs, abstracts and manuscripts.
- Evaluates the business development and market opportunities from a clinical perspective and provides feedback as a member of the clinical team.
- Provides clinical expertise and perspective to the drug discovery teams involved in the clinical candidate selection process.
- Contributes to the development of the clinical development budget across all studies as requested.
- Performs other responsibilities as assigned by Manager and/or senior leadership.
- Participates in the development and execution of advisory boards, investigator meetings and other interactions with external parties as assigned.
- MD .
- A minimum of 4 years of relevant industry experience, preferably board certified in internal medicine or one of its subspecialties. Some experience in inflammation or gout is of value.
- Excellent verbal and written communication skills.
- Experience with Microsoft Office products.
- Troubleshooting and problem solving skills.
- Ability to work independently and as part of a team.
- Some travel is to be expected up to 15%.
- This job may necessitate working outside “regular” work hours.