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

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Reports to: Senior Director, Clinical Development and Operations

Position Summary:

This position will support the implementation of assigned clinical trials for SCYNEXIS. The Clinical Study Manager will have hands-on responsibility and strategic oversight on the planning and execution of clinical activities related to the clinical study centers/regions under his/her responsibility.

Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and other vendors.

Responsibilities:

• Key contributor to the Clinical Operations team responsible for the planning and execution of assigned clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, in line with corporate goals for approval of products
• Participate in the selection of CROs and other vendors to support clinical study operations centers
• Oversee required country regulatory (e.g. FDA, MoH) and country/site IRB/IEC approvals/notifications
• Oversee clinical monitoring quality and adherence to established processes and plans
• Manage the budget and resources allocated to the assigned clinical development activities
• Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community
• Manage consultants and collaborators under their responsibility
• Lead the cross-functional global team for execution of the study and be the primary operational contact for the study
• Liaise with and provide information to regulatory affairs as required
• Liaise with the pharmaceutical development team to ensure proper planning and distribution of clinical trial supplies
• Support the writing of protocols, protocol amendments, informed consents, clinical study reports, initial IND and annual IND updates, investigators brochure and updates, etc.
• Provide operational and strategic input into study documents such as the Monitoring Plan, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
• Inform team members and leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
• Participate in the development of SOPs, facilitate training and ensure compliance for the team under his/her supervision
• Additional duties and responsibilities that may be assigned from time to time

Requirements:

• Minimum Bachelor’s Degree in Science Discipline (Healthcare Degree Preferred)
• 7+ years of current pharma / biotech experience, including Clinical Development and/or Clinical Operations with a minimum of 3-5 years clinical study management experience
• Complex Therapeutic Area Experience such as; oncology, CNS, HIV, Pain, Cardio, etc.
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Vendor oversight experience
• Assume co-monitoring (visit the site with the CRO or inhouse monitor) responsibilities as needed
• Ability to establish relationships with external individuals/organizations (e.g., investigators, KOL's/CROs)
• Strong project and vendor management, analytical and problem-solving skills
• Effective verbal and written communication and interpersonal skills
• Ability to quickly adapt to and manage an environment with rapidly changing organizational needs
• Ability to travel domestically up to 20% if needed; occasional international travel may be required to participate in investigator meetings or conferences

Desired Experience:

• Management of Phase 2 and/or 3 trials
• Onsite monitoring experience
• Oversight of CRO study execution
• Global clinical trial management
• Data Management experience is a plus
• Oncology clinical trial management

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