- Lead and manage the clinical operations team to ensure the successful execution of clinical trials from initiation to completion, including oversight of CROs, vendors, and clinical sites.
- Develop and implement clinical trial protocols, operational plans, and timelines in collaboration with cross-functional teams.
- Drive continuous process improvement initiatives to enhance efficiency and quality in clinical trial execution.
- Provide strategic input into clinical development plans and contribute to the overall development strategy for CNS therapeutic programs.
- Oversee budget planning and management for clinical trials, ensuring optimal resource allocation and cost-effectiveness.
- Foster strong relationships with key stakeholders, including investigators, opinion leaders, and regulatory agencies.
- Stay abreast of industry trends, regulatory requirements, and best practices in clinical operations and program management.
- Advanced degree in life sciences or related field (MD, PhD, PharmD, or equivalent).
- Minimum of 4 years of experience in clinical operations and program management within the biopharmaceutical industry, with a focus on CNS therapeutics preferred.
- Proven track record of successfully leading and managing clinical trials across all phases of development.
- Strong understanding of GCP regulations and regulatory requirements governing clinical trials.
- Excellent leadership, communication, and interpersonal skills with the ability to effectively collaborate across multidisciplinary teams.
- Demonstrated strategic thinking and problem-solving abilities.
- Ability to thrive in a fast-paced, entrepreneurial environment and adapt to evolving priorities.
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Head of Clinical Operations/ Program Manager - Massachusetts, United States - Life Science People
Description
Our client is a pioneering early-stage biotech company dedicated to developing innovative therapies in the Central Nervous System (CNS) therapeutic area. With a focus on groundbreaking research and development, we are committed to bringing transformative treatments to patients in need.
Position Overview: We are seeking a highly skilled and experienced Head of Clinical Operations and Program Management to join our dynamic team. This individual will play a pivotal role in leading the planning, execution, and oversight of our clinical trials while ensuring alignment with our strategic objectives in CNS therapeutics.
Responsibilities:
Qualifications:
