Director, Clinical Operations (Hybrid in Boston, MA)
Salary: $220,000- $245,000
This company is a pioneering biotechnology company dedicated to advancing the field of gene therapy to address unmet medical needs and transform the lives of patients worldwide. Founded on the principles of innovation, collaboration, and patient-centricity, they are committed to developing and delivering breakthrough treatments that harness the power of genetic medicine.
They specialize in the research, development, and commercialization of novel gene therapy approaches aimed at treating a wide range of genetic disorders, rare diseases, and other debilitating conditions.
Position Overview:
The Director of Clinical Operations is a key leadership role responsible for overseeing and managing the clinical operations for a cutting-edge gene therapy company. This individual will play a crucial role in ensuring the successful execution of clinical trials and programs in the field of gene therapy, as well as fostering strong relationships with internal and external stakeholders. The Director of Clinical Operations will lead a team of clinical operations professionals and collaborate closely with other departments to drive operational excellence and achieve organizational goals in this rapidly advancing field.
Responsibilities:
Develop and implement strategic plans for clinical operations in alignment with organizational objectives. Identify opportunities for process improvement and optimization to enhance efficiency and quality.
Provide leadership, guidance, and mentorship to the clinical operations team. Foster a culture of collaboration, innovation, and continuous learning to support professional development and growth. Continue to buildout the clinical operations team
Oversee the planning, execution, and monitoring of clinical trials. Ensure compliance with regulatory requirements, study protocols, and quality standards.
Work closely with cross-functional teams, including clinical development, regulatory affairs, medical affairs, and data management, to drive integrated strategies and deliver comprehensive solutions.
Identify potential risks and challenges in clinical operations and develop mitigation strategies to minimize impact on study timelines and objectives.
Implement and maintain quality management systems to uphold compliance with regulatory requirements and industry standards. Conduct regular audits and assessments to ensure adherence to best practices.
Build and maintain relationships with key internal and external stakeholders, including investigators, opinion leaders, regulatory authorities, and advocacy groups. Represent the organization at relevant meetings, conferences, and events.
Establish key performance indicators (KPIs) and metrics to monitor the performance of clinical operations activities. Analyze data and metrics to drive informed decision-making and continuous improvement initiatives.
Qualifications:
Advanced degree in life sciences, pharmacy, or related field. (e.g., MD, PhD, PharmD)
Minimum of 11 years of experience in clinical operations management within the pharmaceutical or biotechnology industry.
Demonstrated leadership experience with a track record of successfully leading and managing clinical operations teams.
Experience in therapeutic area such as oncology, immunotherapy, or gene therapy is highly desirable.
Strong communication, interpersonal, and problem-solving skills.
Proven ability to build and maintain effective relationships with internal and external stakeholders.
Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
Note: This is a confidential search. All inquiries and applications will be handled with discretion