Director Clinical Operations – Psychedelics / Psychiatrics

W2 only, no C2C, must be authorized to work in the US (both now and in the future).

• Location: Madison, Wisconsin
• Type: Direct Hire
• Job #4229

Do you have strong leadership experience in Clinical Operations / Clinical Trials and experience and a passion for mental health treatment or psychedelics? This could be the perfect leadership role in the next step of your career!

We're looking for a compassionate leader within Clinical Operations that has experience in Sponsor organizations and can assist with the strategic study design, planning, and oversight of clinical trials. The Director, Clinical Operations will oversee multiple aspects of clinical operations to ensure the highest standards of clinical study execution and be at the forefront of mental health solutions. This individual will report directly to the Chief Medical Officer and collaborate cross-functionally with multiple departments, as well as external stakeholders, to lead all aspects of clinical trial execution and department initiatives.

What You'll Do

• Drive the development of comprehensive strategies to optimize clinical trial design, data collection, analysis, and inspection readiness for successful regulatory submissions. Stay abreast of evolving clinical operations regulatory guidelines and requirements, proactively identifying potential challenges or opportunities and recommending appropriate actions to ensure compliance and expedited approvals.
• Oversee the implementation and conduct of company-sponsored clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP)/ICH guidelines, FDA regulations, and department Standard Operating Procedures (SOPs). Ensure excellent study execution from various perspectives, including patient safety, data integrity, quality, compliance, budget, and timeline adherence.
• Collaborate with cross-functional teams to provide expert clinical operational insights for the preparation and review of regulatory documents, such as Investigational New Drug (IND) applications, meeting briefing packages, New Drug Application (NDA) submissions, and other regulatory filings.
• Collaborate with cross-functional stakeholders, both internal and external, to facilitate seamless communication, coordination, and collaboration. Serve as an escalation resource for internal staff (including consultants), Contract Research Organizations (CROs), and other ancillary vendors.
• Oversee clinical trial vendor selection and provide oversight of CROs, consultants, and other ancillary vendors. Ensure effective working relationships, oversee vendor performance, and resolve any issues or concerns.
• Develop and execute strategic initiatives, including the formulation of comprehensive plans, oversight of budgets, allocation of resources, and achievement of key objectives. Continuously monitor progress across projects, identifying potential risks and implementing proactive measures to mitigate them promptly and effectively.
• Identify gaps and inefficiencies in clinical operation systems, processes, and workflows, conducting thorough assessments and analyses. Propose and implement innovative solutions and improvements to enhance operational efficiency, streamline processes, and optimize resource utilization while maintaining compliance with regulatory requirements.
• Collaborate with cross-functional teams to evaluate and select appropriate technology platforms and systems to support clinical operations, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), electronic trial master files (eTMF), and other relevant software. Ensure seamless integration and effective utilization of these systems across clinical programs.
• Develop comprehensive resource plans for clinical programs under oversight, considering project timelines, milestones, and resource requirements. Allocate resources optimally to ensure efficient execution of clinical trials, including staffing needs, vendor management, and budget allocation.
• Manage a team of clinical operations professionals, providing guidance, support, and mentorship. Foster a positive work environment, promote professional growth, and ensure effective collaboration within the team and the organization.
• Prepare and manage the department budget, ensuring financial oversight and adherence to budgetary constraints. In collaboration with finance and accounting staff, monitor clinical trial expenses, identify cost-saving opportunities, and maintain financial accountability.
• Drive initiatives to improve operational efficiency and excellence within the clinical operations function. Develop and update procedural documents, including GCP SOPs, to ensure adherence to quality standards and compliance requirements.
• Build and maintain positive relationships with internal and external stakeholders, including donors, investigators, study teams, key opinion leaders, and clinical trial sites. Foster effective communication and collaboration to support successful study outcomes.
• Demonstrate thorough knowledge of and coach others in the appropriate application of clinical research regulations, GCPs, and best practices in compliance with applicable company SOPs and policies.
• Fully support the Quality Policy by incorporating quality into all aspects of work and maintaining compliance with all quality requirements, including training.
• Understands and complies with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring

• At least 5 years of direct experience as a Director of Clinical Operations or higher in a Sponsor Organization.
• A BS/BA or higher degree in a relevant scientific discipline.
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
• Well-organized and detail-oriented with strong written and verbal communication skills.
• Demonstrated skills in internal and external collaboration among cross-functional teams, vendors, and scientific and clinical advisors.
• Ability to travel up to 25% of the time.

Ideal (but Not Required) Qualifications

• Psychedelic clinical trial experience.
• Prior experience as a Director of Clinical Operations in a Psychedelic Drug Development company, or in a pharmaceutical company focused on psychiatric conditions.
• Central Nervous System (CNS) clinical trial experience.

Apply Now and move your career forward with a great team and non-profit leader in mental health!

Questions? Contact Andie Veach directly at Andie@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.