Sr. Director, Scientific Affairs (Specialty Labs)

Overview

Senior Director, Scientific Affairs leading the Scientific Affairs team within Specialty Lab Services at Precision for Medicine. The role drives operational considerations for RFPs and bid defense meetings, owns global third-party lab relationships, and supports proposals and business development.

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. 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 as they pertain to internal laboratories and 3PL partners, in partnership with the 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 for BDMs.
• Collaborate with lab operations to provide innovative solutions in conjunction with 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.
• Experience establishing standardized processes and quality systems, and aligning 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 of all phases of clinical trials.
• Management or oversight of third-party lab partners.

Nice to have

• Advanced degree (PhD preferred).

Details

• Location: Remote, United States.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.
• Eligible for a discretionary annual bonus.