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 the company. As part of this team, they will drive and support the operational considerations the company 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 the company 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 the company to stay at the forefront of innovation and maintain their competitive edge as a scientifically driven engaged partner the company our biotech and pharma clients.

ESSENTIAL FUNCTIONS

Provide operational support

• Collaborate with scientific, operational, business development, proposal colleagues and other the company 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 the company 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 the company 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 the company 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 the company 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 the company colleagues in aspects of strategy and assessing specifications the company clinical research studies.

Represent the company in client meetings

• Support capabilities presentations and pre-award client meetings

• Provide feasibility and scientific landscape direction input and support the company BDMs.

• Collaborate with lab operations to provide innovative solutions in conjunction with scientific strategy and consulting, as needed, the company 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 the company the role including operational protocol analysis and budget review.

• Strong experience in the company’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

The company is required by law in some states or cities to include a reasonable estimate of the compensation range the company 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 the company the applicable geographic differential associated with the location at which the position may be filled. At the company, it is not typical the company an individual to be hired at or near the top of the range the company their role and compensation decisions are dependent on the facts and circumstances of each case.  This role is also eligible the company a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off the company sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$181,400 — $225,000 USD

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