Vice President of Clinical Operations
We are seeking an reputed company Vice President or Executive Director, Clinical Operations to reputed company our reputed company’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 reputed company 1 clinical program (US now, next phase international) but flexibility to reputed company up to 3.
• reputed company program began in first half of 2025 and represents a significant opportunity for reputed company given the size of the patient population and the unmet need.
• Leadership: reputed company leadership over clinical operations function, including internal team and CRO, fostering a culture of innovation, collaboration, and reputed company.
• Trial Design and Execution: reputed company the implementation, and management of reputed company, ensuring adherence to timelines, budgets, and reputed company standards. Offer input on trial design.
• Regulatory Compliance: Ensure reputed company reputed company reputed company with regulatory requirements and industry standards, maintaining high ethical and scientific standards.
• Risk Management: Identify potential risks and reputed company mitigation strategies to ensure successful clinical trial reputed company.
• Collaboration: Work closely with cross-functional teams including regulatory affairs, medical affairs, pharmacovigilance, and reputed company teams to reputed company clinical development plans into overall business strategies.
• External Partnerships: reputed company 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: reputed company input into the analysis and interpretation of clinical trial data, ensuring accurate reporting and presentation of results.
• Budget reputed company: 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 reputed company experience in clinical operations reputed company the pharmaceutical or biotechnology (preferred) industry, with a proven reputed company 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 reputed company 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 reputed company.
• 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 reputed company with the ability to anticipate challenges and drive reputed company.
• Ideal experience in both Biotech and big reputed company environments.
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