Planet Pharma ยท 1 day ago
Phase I Site Operations Director
Stuart, FL
Full-time
Onsite
Director/ExecutivePlanet Pharma is seeking a Phase I clinical research professional with a background in medical and operational clinical research site management. The role involves designing, building, and leading a specialized clinical trial unit for early-phase AD studies, focusing on strategic and operational management of clinical trials.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Operational management
Team and talent management
Regulatory and quality oversight
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 alongside 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
Qualification
Required
Phase 1 clinical research professional with medical and/or operational clinical research site background
Must have Phase 1 unit experience
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 alongside 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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
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