Head Of Clinical Operations

This newly created position is mission critical to Gilgamesh as we progress our clinical stage assets forward. As founding leader of the Clinical Operations function, you will oversee strategic and tactical operational leadership of multiple clinical programs. You will take primary responsibility for meeting quality completion within planned timelines and spending within established budgets. You will be integral to vendor / CRO selection, negotiation, contract agreement and management of responsibilities throughout trials. You must be a strong team player, but likewise motivated to work productively and in a hands-on primarily remote environment. As Gilgamesh grows, you will be involved in hiring, mentoring, and managing responsibilities of additional clinical trial associates and vendors to assure successful project delivery.

Key Responsibilities

• Take lead role in building clinical development infrastructure focused on implementation of trials with psychedelic drugs, potentially using combined psychotherapy, biomarkers, and digital therapeutics as well as established rating scales and cognitive testing methodology
• Take lead role in clinical operational vendor and CRO selection and negotiation. This encompasses defining the services required, including managing highly complex negotiations with key vendors and CROs throughout the trial
• Oversee authoring of clinical documents (directly or through vendors), including: investigator brochures, clinical study protocols, informed consent forms, clinical study reports, and briefing documents
• Liaise with clinical site staff and Investigators as appropriate throughout trial to ensure optimal sponsor-site relationships and performance against timelines and budgets
• Partner with Gilgamesh CMC function to ensure effective supply and packaging of drug substance for clinical trial management and quality requirements within the regulatory environment
• Ensure oversight of activities outlined in various study plans (data management, safety management, and study communication plans).
• Initiate and conduct preparation for site and vendor audits as required.
• Liase with QA function to ensure audits are conducted in a timely manner and corrective action plans are implemented
• Liaise with Pharmacovigilance function to ensure all safety reporting and corrective actions are fully implemented
• Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• At least 10 years of experience in positions of leadership in a clinical operations role in the pharmaceutical industry
• Key expertise preferred, but at least some experience in early psychiatric drug development
• Extensive experience in the design, conduct and regulatory requirements of early- and mid-stage drug development preferably on a global basis
• Extensive experience managing CROs, budgets, and timelines throughout trial planning, start up and conduct of complex protocols
• Proven track record of effective clinical support for clinical aspects of regulatory submissions (e.g., IND, NDA, MAA, PIP) and data management liaison
• Experience monitoring and supervising of GCP conduct of clinical sites and conducting PSVs, SIVs, IMVs, and COVs required.
• Working expertise using Microsoft Office software, including Microsoft Project, and ability to independently create and work with documents, slides, spreadsheets and Gantt Charts.
• Strong communication skills (verbal and written), presentation skills and organizational skills, with ability to multi-task
• Thrive in a challenging, fast-paced environment that requires resourcefulness, innovativeness and clear thinking to adapt to new situations as they arise
• Proactively seek out collaboration with other team members and are willing to develop, coach and motivate junior as well as other non -clinical members of the team
• Excitement about mission at Gilgamesh to develop novel, cutting-edge psychedelic therapeutic interventions in neuropsychiatry

EDUCATION

• PhD , BS, RN, or MA/MPH or equivalent in a scientific or healthcare field.

COMPENSATION

An attractive compensation package commensurate with this leadership role will be provided.