Sr. Director, Scientific Affairs (Specialty Labs)

JOB SUMMARY

The Senior Director Scientific Affairs will be a core team leader of the Scientific Affairs team within Specialty Lab Services (SLS) a Department at Precision for Medicine. As part of this team, they will drive and support the operational considerations for the RFPs, bid defense meetings (BDMs) and own all global third-party lab relationships. This will entail drawing on strong experience of operationalizing complex clinical studies globally, knowledge and analysis of the competitive environment and analysis of the study design and rationale.

The Senior Director Scientific Affairs and team members will support the proposals and business development teams by representing Precision lab operations at pre-award meetings and internal and external kick off meetings. This team will also own global 3PL relationships in the context of capabilities and proposal writing.  In addition, this team may lead specific projects that will enable Precision for Medicine to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner for our biotech and pharma clients.

ESSENTIAL FUNCTIONS

Provide operational support:

• Collaborate with scientific, operational, business development, proposal colleagues and other Precision functional leadership as required to:
• Hire, train develop and mentor direct reports.
• Own, maintain and report all staff and department metrics including but not limited to capacity, productivity and turnaround time.
• Create, develop, and refine the specifications for potential opportunities specifically regarding operational considerations from the client protocol such as enrollment, feasibility, study timelines, startup timelines.
• Collaborate and work closely with colleagues from lab operations and global lab vendor management specialists to provide protocol interpretation and assay specifications for all laboratories globally, particularly with respect to understanding timelines, assay endpoints and budgets.
• Own global 3PL relationships, attend post-award monthly and governance meetings, collect and provide metrics, reconcile invoices and billing.
• Create specification sheets from protocols to gain quote information for the BD/ proposal teams. Inquire about capabilities as needed.
• Develop proposal text that describes the 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 the development and finalization of study proposal budgets as it pertains to internal Laboratories and 3PL partners for potential opportunities in partnership with the proposals and business development teams.
• Work closely with colleagues in 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 has the information and rationale behind the strategy position and is ready to execute on deliverables.
• Mentor and train scientific affairs colleagues and Precision colleagues in aspects of strategy and assessing specifications for clinical research studies.

Represent Precision for Medicine in client meetings:

• Support capabilities presentations and pre-award client meetings
• Provide feasibility and scientific landscape direction input and support for BDMs.
• Collaborate with lab operations to provide innovative solutions in conjunction with scientific strategy and consulting, as needed, for clients who are seeking input
• Work with Lab Operations, Vendor Management specialists, and the Project management team to support post-award collaboration to ensure robust and timely delivery of data and milestones.
• Represent the Company by attending industry meetings, speaking engagements, booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals and digital media.

REQUIREMENTS

• Bachelors degree in life sciences discipline (Advanced degree PhD preferred) or equivalent relevant experience
• 15+ years in the CRO/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 the required activities for the role including 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