Vice President of Clinical Operations
We are seeking an experienced Vice President or Executive Director, Clinical Operations to lead our client’s clinical program(s) in Immunology. Reporting directly to the CEO, this role will play crucial in overseeing the trial(s), contributing to clinical program design, and ensuring successful execution of development plans. Position title will be based on experience level and one’s ability to take on more strategic aspects of clinical development and trial design.
Key Responsibilities:
• Willingness to lead 1 clinical program (US now, next phase international) but flexibility to lead up to 3.
• Lead program began in first half of 2025 and represents a significant opportunity for the company given the size of the patient population and the unmet need.
• Leadership: Provide leadership over clinical operations function, including internal team and CRO, fostering a culture of innovation, collaboration, and excellence.
• Trial Design and Execution: Oversee the implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards. Offer input on trial design.
• Regulatory Compliance: Ensure all clinical trials comply with regulatory requirements and industry standards, maintaining high ethical and scientific standards.
• Risk Management: Identify potential risks and develop mitigation strategies to ensure successful clinical trial outcomes.
• Collaboration: Work closely with cross-functional teams including regulatory affairs, medical affairs, pharmacovigilance, and commercial teams to integrate clinical development plans into overall business strategies.
• External Partnerships: Oversee the management of clinical investigators, CROs, and other external partners to support clinical trial activities. Contribute to the management of relationships with key opinion leaders.
• Data Analysis: Provide input into the analysis and interpretation of clinical trial data, ensuring accurate reporting and presentation of results.
• Budget Oversight: Manage clinical development budgets and resources effectively, optimizing allocation to maximize return on investment.
Requirements / Qualifications:
• BS, MS, or PhD in a relevant scientific discipline.
• Minimum of 10 years of progressive experience in clinical operations within the pharmaceutical or biotechnology (preferred) industry, with a proven track record of successful drug development.
• Clinical experience through Phase 3, ideally including drug approval.
• Experience in Registrational/Pivotal stage/drug approval
• Large molecule biotech experience.
• Rare disease or other experience with challenging enrollment preferred.
• Strong leadership skills with experience managing and developing high-performance teams.
• Experience with CRO initiation/ management and partnership with Quality to build GCP compliance
• In-depth knowledge of clinical trial design, execution, and regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels.
• Travel - may need to travel for quarterly BOD meetings and potentially a few other times per year. Possible travel to trial sites or key industry meetings.
• Strategic mindset with the ability to anticipate challenges and drive innovative solutions.
• Ideal experience in both Biotech and big pharma environments.
Apply Now
Apply Now
Key Responsibilities:
• Willingness to lead 1 clinical program (US now, next phase international) but flexibility to lead up to 3.
• Lead program began in first half of 2025 and represents a significant opportunity for the company given the size of the patient population and the unmet need.
• Leadership: Provide leadership over clinical operations function, including internal team and CRO, fostering a culture of innovation, collaboration, and excellence.
• Trial Design and Execution: Oversee the implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards. Offer input on trial design.
• Regulatory Compliance: Ensure all clinical trials comply with regulatory requirements and industry standards, maintaining high ethical and scientific standards.
• Risk Management: Identify potential risks and develop mitigation strategies to ensure successful clinical trial outcomes.
• Collaboration: Work closely with cross-functional teams including regulatory affairs, medical affairs, pharmacovigilance, and commercial teams to integrate clinical development plans into overall business strategies.
• External Partnerships: Oversee the management of clinical investigators, CROs, and other external partners to support clinical trial activities. Contribute to the management of relationships with key opinion leaders.
• Data Analysis: Provide input into the analysis and interpretation of clinical trial data, ensuring accurate reporting and presentation of results.
• Budget Oversight: Manage clinical development budgets and resources effectively, optimizing allocation to maximize return on investment.
Requirements / Qualifications:
• BS, MS, or PhD in a relevant scientific discipline.
• Minimum of 10 years of progressive experience in clinical operations within the pharmaceutical or biotechnology (preferred) industry, with a proven track record of successful drug development.
• Clinical experience through Phase 3, ideally including drug approval.
• Experience in Registrational/Pivotal stage/drug approval
• Large molecule biotech experience.
• Rare disease or other experience with challenging enrollment preferred.
• Strong leadership skills with experience managing and developing high-performance teams.
• Experience with CRO initiation/ management and partnership with Quality to build GCP compliance
• In-depth knowledge of clinical trial design, execution, and regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels.
• Travel - may need to travel for quarterly BOD meetings and potentially a few other times per year. Possible travel to trial sites or key industry meetings.
• Strategic mindset with the ability to anticipate challenges and drive innovative solutions.
• Ideal experience in both Biotech and big pharma environments.
Apply Now
Apply Now