Sr. Director, Scientific Affairs

Precision for Medicine; United States; Remote; USD 181,000 - 225,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance and disability benefits

Parental leave

Paid time off

Job summary

Precision for Medicine seeks a Senior Director of Scientific Affairs to lead our global laboratory operations within Specialty Lab Services. This role drives protocol interpretation, budgets, and 3PL partnerships, supporting RFPs, bid defenses, and strategic proposal writing to keep Precision at the forefront of scientific partnerships.

You will mentor the scientific affairs team, coordinate with business development, and represent Precision in client meetings and industry forums, delivering

Qualifications

• 15+ years in CRO/Lab industry or equivalent with global leadership experience.
• Experience leading global laboratory networks and multi-site operations.
• Proven ability to analyze client protocols and budgets for proposals.
• Experience overseeing third-party lab partners.
• Strong background in operational delivery of clinical trials.

Responsibilities

• Provide operational support across scientific, operational, BD, and proposal teams.
• Hire, train, develop and mentor direct reports.
• Own, maintain and report staff and department metrics (capacity, productivity, turnaround).
• Create specifications for opportunities from client protocols (enrollment, timelines, startup).
• Collaborate with lab operations and 3PL teams on timelines, endpoints and budgets.
• Own global 3PL relationships and manage quotes and invoicing.
• Create specification sheets from protocols for BD/proposals.
• Develop proposal text describing operational assay development, validation or analysis.
• Ensure proposals reflect strategic, operational, scientific and clinical development planning.
• Support study budgets with internal labs and 3PL partners.
• Work with BD and Project Management to transition strategic approach before internal kick-offs.
• Participate in post-award meetings to ensure readiness and execution.
• Mentor scientific affairs colleagues on strategy and study specifications.
• Represent Precision for Medicine in client meetings and industry forums.
• Support feasibility inputs for BD teams and provide scientific landscape direction.
• Collaborate with lab operations to propose innovative solutions for clients.
• Support post-award collaboration to ensure timely delivery of data and milestones.
• Represent the company at industry meetings, speaking engagements and publications.

Skills

Global lab leadership

Budget review

Protocol analysis

Third-party labs

CRO/Lab experience

Education

Bachelor's degree in life sciences

PhD preferred

Job description

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

Reasonable estimate of the current range

$181,400—$225,000 USD

• discretionary annual bonus
• health insurance
• retirement savings benefits
• life insurance and disability benefits
• parental leave
• paid time off for sick leave and vacation
• among other benefits

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

CANDIDATES MUST BE LEGALLY AUTHORIZED to work in the country of employment without employer sponsorship.