Reporting to: Chief Medical Officer
This position will lead the implementation of clinical development programs for SCYNEXIS. He/she will have hands-on responsibility and strategic oversight on the planning and execution of clinical activities (i.e., phases 1-4) and will lead the clinical development team.
Responsibilities
- Lead Clinical Development programs, including interactions with discovery, safety, marketing, regulatory, research and other functions.
- Responsible for the design, planning and execution of clinical trials that meet the standards of excellence for ethics, scientific merit and regulatory compliance, in line with corporate goals for approval of products.
- Manage consultants and collaborators in the clinical research program.
- Oversee clinical operations activities, including initiation, planning, execution, control, closing and reporting of clinical trials, globally.
- Liaise with and provide information to regulatory affairs as required.
- Manage the budget and resources allocated to Clinical Development programs.
- Represent the Company as needed as a senior representative to a variety of scientific, business and government groups/agencies.
- Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community.
- Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed).
- Select and manage CROs and vendors to support clinical development activities.
- Liaise with the pharmaceutical sciences team to ensure proper planning and distribution of clinical trial supplies.
- Additional duties and responsibilities that may be assigned from time to time.
Requirements
- MD required.
- 15+ years of current pharma/biotech experience, including 7+ years of experience leading a Clinical Development and/or Clinical Operations team.
- Global experience within all phases of drug development with advanced understanding of other functions, including but not limited to: Translational Research, Non-Clinical, DMPK, Manufacturing/Supply Chain, Commercial, Regulatory and Medical Affairs
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Must have experience in designing clinical trial strategies to obtain regulatory approval.
- Ability to apply clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Application of Project Management tools, methodologies, practices, risk analysis, decision analysis and contingency planning.
- Ability to establish relationships with external individuals/organizations (e.g., investigators, KOLs/CROs) and represent the Company in public (e.g., scientific conferences, advisory boards).
- Ability to identify realizable solutions and alleviate potential hurdles in unique clinical trial situations to ensure trial success.
- Effective interpersonal skills: one-on-one and in groups.
- Comfortable at managing an environment with rapidly changing organizational needs.
- Persuasive, effective and flexible inter-personal interactions at all levels of the organization.
- Entrepreneurial spirit, initiator, and generator of positive group dynamics.