Associate Director, Precision Medicine Operations
Regeneron's Precision Medicine organization is seeking an Associate Director to join our team. In This Role, a Typical Day May Include: The Associate Director, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to provide strategic oversight of biomarker operational delivery and clinical laboratory deliverables across the portfolio; ensuring that study start timelines are met, provide risk management and collaborate with stakeholders for all aspects of biomarker and clinical laboratory deliverables (from study conduct, sample management testing to launch). This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.
Responsibilities
- Perform strategic and clinical laboratory portfolio management for Regeneron clinical trials based on the requirements in a clinical trial protocol and schedule of events/assessments.
- Lead program teams through operational lab delivery; review clinical laboratory operations timelines and risks and be able to manage and communicate risks and ensure study starts and data delivery are aligned with expectations.
- Be a subject matter expert on central and specialty laboratory processes, lab project management, vendor management, ICH/GCP and leverage this knowledge to be a trusted stakeholder and ensure clinical laboratory deliverables.
- Collaborate with stakeholders including Precision Medicine Strategy Leads (PMSL) and Clinical Laboratory Strategy Management team to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies, identifying and tracking risks and decisions, creating mitigation plans. Manage the delivery of complex biomarker deliverables with internal and external colleagues.
- Inform and shape clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines.
- Develop strong relationships and trust with internal and cross-functional partners, senior leadership, including Precision Medicine Clinical Lab Study Management and others within Global Development to manage and implement program-level clinical laboratory management.
- Oversee operational aspects of clinical trial laboratory implementation and communicate effectively both externally and internally. Identify solutions for barriers to success in the clinical laboratory space as needed.
- Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction. Demonstrate authority for the studies related to the program, with frequent executive summaries. Establish as a leader for the program and can dive into the details when required, with attention to detail.
- Bridge laboratory clinical trial operations work through research teams and tech centers at Regeneron, managing timelines for the lab delivery in clinical trials and other human sample projects to ensure seamless execution and adherence to project deadlines.
- Provide subject matter expertise on human sample management projects, including acquiring samples from outside sources and executing new project ideas to support innovative research initiatives.
- Design and develop processes to address identified gaps and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment.
Decision Making and Consistency of Operational Delivery
- Lead and facilitate decision-making forums for clinical lab strategy within the portfolio, while identifying and adjusting new processes as required with forward-thinking, big-picture skill sets.
- Demonstrate knowledge and understanding of clinical laboratory trial requirements on the program and execute strategic operational decisions. Ensure the laboratory portion of the studies is harmonized for the assigned program from onset to final delivery.
- Demonstrate leadership, proactive problem-solving, prioritization, and collaboration in a team-based environment; line management of staff, including recruitment, development, coaching, mentoring and performance management; and high emotional intelligence to ensure program success.
Qualifications
- Bachelor's Degree with a minimum of 8 years' pharmaceutical experience in matrix interaction, preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.
- Minimum of 5 years' experience with Clinical Trials, focusing on clinical sample collection.
- Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
- Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.
- Clinical study knowledge demonstrated by knowledge in science and technology.
- Demonstrated experience in stakeholder management, leading internal and external meetings and solutioning skills.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, ethnic origin, civil status, age, citizenship status, sexual orientation, disability, or any other protected characteristic in accordance with applicable laws and regulations. The Company will provide reasonable accommodation to known disabilities or chronic illnesses for an otherwise qualified applicant, unless accommodation would impose undue hardship on the operation of the business.
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