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Phase I Site Operations Director
Job Description
Seeking a phase 1 clinical research professional with medical and/or operational clinical research site background, must have Phase 1 unit experience. Will work under senior leadership CEO and COO to design, build, and lead a specialized clinical trial unit for early-phase AD studies. This role involves the strategic and operational management of complex clinical trials, identifying key staffing positions needed and hiring quality individuals, medical and safety oversight, targeted recruitment, and regulatory expertise to create, operate and oversee a functional phase 1 unit, from the ground up. The goal is to create a compliant, safe, and efficient environment complete with facilities, participants and multidisciplinary staff for conducting "first-in-human" clinical trials, where new drugs are tested for safety and dosing in a small group of volunteers.
Key responsibilities:
1. Cooperative strategic leadership and planning
- Develop the program strategy: Work with institutional and executive leadership to define the vision for the early-phase clinical trial unit.
- Build the unit infrastructure: Manage the creation of the facility, which must have ICU-level readiness for intensive 24/7 monitoring and emergency response protocols.
- Strategic planning: Define the unit's short-term and long-term goals and develop a strategic business plan to ensure continued growth and success.
- Oversee trial delivery: Direct studies, ensuring they are executed on time, within budget, and to the highest quality standards.
- Manage complex logistics: Drive and optimize the unit's operational processes, from protocol execution and regulatory submissions to patient recruitment and data collection.
- Track Metrics
- Assemble and lead the team: work along side executive leadership to recruit, hire, and mentor a small team of specialized Phase 1 Unit staff.
- Ensure staff training: ensure all personnel are trained and compliant with the SOPs, phase 1 unit operations, clinical trial protocols and regulatory requirements.
- Foster collaboration: Facilitate effective communication and teamwork.
- Ensure compliance: Guarantee that all trials adhere to stringent ethical and regulatory standards, including Good Clinical Practice (GCP) guidelines and FDA regulations.
- Collaborate on audits: work alongside operational leadership and QA/QC Department to maintain audit readiness standards and prepare for any sponsor or FDA audit.
- Risk Management: Proactively identify, report and collaboratively mitigate risks that could jeopardize study timelines, budgets, or patient safety.
- Experience: experience in early-phase clinical trial management, including experience in a phase 1 unit.
- Education: Any advanced degree
- Technical skills: Deep knowledge of ICH-GCP guidelines, FDA regulations, and the drug development process.
- Leadership skills: Excellent project management, problem-solving, and communication skills are essential for leading multi-functional teams.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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