Sr. Director, Scientific Affairs

Precision Medicine Group; 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 & disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group seeks a Senior Director of Scientific Affairs to lead the Scientific Affairs team within Specialty Lab Services, driving operational support for RFPs, BDMs, and global third-party lab relationships. The role requires deep experience in operationalizing complex clinical studies and strategic, scientifically driven proposal development.

The candidate will mentor staff, manage metrics, and collaborate with cross-functional teams to ensure robust budgets, timelines, and

Qualifications

• Bachelors in life sciences; PhD preferred or equivalent experience.
• 15+ years in CRO/lab industry or equivalent.
• Leadership of a global laboratory network and multi-site operations.
• Experience in budget reviews and operational protocol analysis.
• Experience managing third-party lab partners and vendor relationships.

Responsibilities

• Provide operational support and develop specifications for opportunities from client protocols.
• Hire, train, mentor and manage staff; report department metrics.
• Develop budgets for study proposals in collaboration with proposals teams.
• Create protocol interpretations, assay specifications and timelines for global labs.
• Lead and participate in post-award meetings to ensure timely data delivery.
• Represent Precision in client meetings and pre-award/support activities.
• Mentor colleagues in strategic planning and operational execution.

Skills

Global lab leadership

Budget development

Operational feasibility

Proposal development

Vendor management

Education

Bachelor's degree in life sciences

PhD preferred

Job description

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

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.

• The role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$181,400 - $225,000 USD

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