Reports to: Chief Medical Officer
Position Summary:
The Executive Director, Clinical Development will lead the implementation of clinical development programs for SCYNEXIS. This position will have hands-on responsibility and strategic oversight on the planning and execution of clinical activities (i.e. phases I-IV) and will provide leadership to 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 aspects of Clinical Development and provide updates as required to the Executive and Senior Management Teams and Board of Directors
- 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, preferably with specialization in Infectious Disease
- Experience in conducting clinical trials intended to obtain regulatory approvals. Preferably 10+ years of current pharma / biotech experience, including 5+ years’ experience leading a Clinical Development and/or
- Clinical Operations team and/or participating as principal or associate investigator in industry sponsored clinical research
- 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
- 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, KOL's/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
- Effective at managing an environment with rapidly changing organizational needs
- Persuasive, effective and flexible in personal interactions at all levels of the organization