Join a dynamic immunology biotech as the Associate Director of Clinical Operations. We're seeking a seasoned professional to oversee and lead the clinical operations aspects of our immunology research and development programs. Your role will involve strategic planning, operational execution, and team management to drive the successful implementation of clinical trials and studies.
Responsibilities:
- Lead the planning and execution of clinical trials for immunology therapeutics, ensuring adherence to protocols, timelines, and budgetary constraints.
- Collaborate with cross-functional teams including clinical development, regulatory affairs, and medical affairs to ensure alignment of clinical operations with overall development strategies.
- Provide leadership and mentorship to the clinical operations team, fostering a culture of excellence, innovation, and collaboration.
- Oversee vendor selection, management, and performance to ensure high-quality deliverables and adherence to contractual agreements.
- Develop and implement standard operating procedures (SOPs) and best practices to optimize clinical trial processes and ensure compliance with regulatory requirements.
- Proactively identify risks and issues related to clinical trial conduct and develop mitigation plans to ensure successful study outcomes.
- Collaborate with clinical sites and investigators to ensure smooth study initiation, conduct, and closeout activities.
- Drive continuous improvement initiatives to enhance efficiency, quality, and productivity within the clinical operations function.
- Represent the clinical operations team in meetings with internal stakeholders, external partners, and regulatory agencies as needed.
- Stay abreast of industry trends, regulations, and best practices in clinical operations to inform strategic decision-making and ensure compliance.
Qualifications:
- Degree in life sciences, pharmacy, or related field.
- Minimum of 7-10 years of experience in clinical operations within the biopharmaceutical or biotechnology industry, with specific experience in immunology preferred.
- Demonstrated leadership experience managing clinical operations teams and overseeing multiple clinical trials simultaneously.
- In-depth knowledge of clinical trial regulations, guidelines, and industry standards (e.g., ICH-GCP).
- Strong interpersonal, communication, and negotiation skills with the ability to effectively collaborate with internal and external stakeholders.
- Proven track record of successful vendor management and negotiation.
- Strategic thinker with the ability to develop and execute operational plans in alignment with corporate objectives.
- Detail-oriented with excellent organizational and problem-solving skills.
- Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.
- Commitment to upholding ethical standards and maintaining the highest level of integrity in all aspects of work.
