Sr. Director, Scientific Affairs (Specialty Labs)

Overview

Senior Director, Scientific Affairs leading the Scientific Affairs team within Specialty Lab Services at Precision Medicine Group, supporting RFPs, bid defense meetings and global third-party lab relationships.

What you'll do

• Hire, train, develop and mentor direct reports.
• Own, maintain and report all staff and department metrics including capacity, productivity and turnaround time.
• Create, develop and refine specifications for potential opportunities, specifically operational considerations from the client protocol such as enrollment, feasibility, study timelines and startup timelines.
• Collaborate with lab operations and global lab vendor management specialists to provide protocol interpretation and assay specifications for all laboratories globally, particularly regarding timelines, assay endpoints and budgets.
• Own global 3PL relationships, attend post-award monthly and governance meetings, collect and provide metrics, and reconcile invoices and billing.
• Create specification sheets from protocols to obtain quote information for the BD and proposal teams, and inquire about capabilities as needed.
• Develop proposal text describing operational assay development, validation or sample analysis, and conduct a comprehensive proposal review prior to sponsor delivery, including any 3PL quotes.
• Ensure proposals reflect robust strategic, operational, scientific and clinical development planning.
• Support development and finalization of study proposal budgets for internal laboratories and 3PL partners, in partnership with proposals and business development teams.
• Work with Business Development and Project Management to transition the operational strategy approach ahead of internal kick off meetings with lab operations.
• Participate in post-award meetings to ensure the study team understands the strategy rationale and is ready to execute on deliverables.
• Mentor and train scientific affairs colleagues and Precision colleagues in strategy and in assessing specifications for clinical research studies.
• Support capabilities presentations and pre-award client meetings, and provide feasibility and scientific landscape direction input for BDMs.
• Collaborate with lab operations to provide innovative solutions alongside scientific strategy and consulting for clients seeking input.
• Work with Lab Operations, Vendor Management and Project Management to support post-award collaboration and ensure robust, timely delivery of data and milestones.
• Represent the company at industry meetings, speaking engagements and booth exhibitions, and publish scientific or industry articles in journals and digital media.

What you'll need

• Bachelor's degree in a life sciences discipline, or equivalent relevant experience.
• 15+ years in the CRO or lab industry, or equivalent relevant experience and/or demonstrated competencies.
• Demonstrated experience leading and influencing a global laboratory network, including oversight of multi-site laboratory operations, establishment of standardized processes and quality systems, and alignment of regional laboratories to enterprise-wide strategic, operational and compliance objectives.
• Relevant experience in operational protocol analysis and budget review.
• Strong experience in Precision's identified target therapeutic area clinical development, focused on operational delivery considerations, strategy, feasibility, budget development and operational execution across all phases of clinical trials.
• Management or oversight of third-party lab partners.

Nice to have

• Advanced degree (PhD preferred).

Details

• Remote, United States.
• Eligible for a discretionary annual bonus, health insurance, retirement savings, life and disability insurance, parental leave, and paid time off.
• Reasonable estimate of current compensation range: $181,400 to $225,000 USD.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.