Specialty biotech/pharma company, focused on innovation and specialty care. Main mission: To develop and commercialize high potential specialty drugs to make a life-changing impact on patients with the greatest medical need. Many times these are orphan drug opportunities that are neglected by other biotech companies in the industry. All of the diseases that company target are serious, debilitating and often life threatening illnesses. These company products are developing and on track to be the first or among the first drugs ever approved for the conditions they target.
The Chief Medical Officer and Head of Research and Development provides leadership and direction for the pipeline of clinical development programs for biotech company is responsible for the strategy, direction and execution of the company’s clinical development plans. This role is a key member of the senior leadership team which determines and oversees research and drug development and sets the overall strategic direction of the company. This is a unique opportunity to be a major contributor to the success of a well-positioned, stable, growth orientated biotech/bioscience company.
- Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the company’s strategic and tactical goals/objectives.
- Provide hands on leadership to the entire R&D team, including but not limited to clinical, regulatory, research, etc. for the successful planning and execution of each clinical trial.
- Plan and develop the clinical development strategies for Phase I-IV programs.
- Support all clinical aspects of implementing and overseeing the Phase III clinical study for specialty drug development.
- Manage activities of the CRO in conjunction with other members of the team.
- Ensure that the company’s clinical team fully adheres to good clinical practice.
- Work with CRA’s, clinical pharmacologists, medical writers, statisticians, data management, members of multidisciplinary project teams and their managers to review and interpret data.
- Contribute to the preparation of abstracts, presentations and manuscripts.
- Work with clinical team and other resources to select trial investigators and clinical sites.
- Ensure that appropriate resources are utilized to provide expert and timely support of clinical trials, including the selection and management of external entities (such as CRO’s and other vendors).
- Achieve established timelines and budgets.
- Attend clinical, scientific and investigator meetings representing the company as a medical expert regarding drug development candidates.
- Oversees the portfolio management activities for the company to ensure appropriate objectives and resources are deployed to meet strategic portfolio plans delivering on key milestones to advance all of the company’s products in development.
- Responsible for representing the company with regulatory and legislative agencies (e.g., FDA, etc), addressing the scientific and medical/health aspects of the company’s product portfolio.
- Provides guidance on health-related matters to leaders across the company and with outside health/medical and regulatory organizations.
- Works closely with the VP of Business Development to search and evaluate new opportunities.
- Supervisory responsibilities include dept employee management and performance tracking; hiring and career development.
- Medical degree, either a M.D. or a D.O
- Board certified in a specialty
- Therapeutic areas desired: Psychiatry, CNS, Neurology,
- Advanced degree in management, such as M.B.A desired
- Valid medical license
- 10+ years clinical development programs in specialty therapeutic area and drug development
- 3 – 5+ years experience working in a team environment and 2 – 3 years experience in a supervisory position managing direct reports
- 3+ years experience managing budgets
- Excellent written, verbal, and presentation communication skills
- Travel up to 25%
up to $400K+ plus 40% Annual Bonus + Equity package
Greater Chicago Area/MidWest
No, not at this time.
CP - 9822