Sr. Director Scientific Services

Position Summary:

The Senior Director, Scientific Services will lead the scientific team, create and implement the scientific overall direction of the Precision laboratory and be instrumental in helping Precision achieve its goals of delivering exceptional services to Precision’s diverse, innovative and global biopharmaceutical clients. This includes formulating and implementing a strategic scientific plan to support translational medicine clinical trials, primarily, but not solely, in the Immuno-Oncology and autoimmune/inflammatory space. The Senior Director, Scientific Services must be able to interpret client requests and lead the design of experimental plans that match client specifications/requirements and be able to communicate the plan and progress to the client, along with executing and reporting the work according to agreed timelines and under the appropriate regulations (GCLP, GLP, CAP, CLIA, etc.).

The Senior Director, Scientific Services must demonstrate both technical and scientific leadership as well as exceptional skills in building and leading a multi-faceted team in a competitive landscape.  Will influence other groups and be viewed as a leader across Precision for Medicine (PfM).

Essential functions of the job include but are not limited to:

• Lead the development and implementation of scientific services to support the clinical trial needs of Precision customers.
• Track project progress and ensure timely delivery to client standards.
• Hire, coach, mentor and train scientists and ensure they are working to PfM quality standards.
• Develop the scientific culture of the organization; leads and develops scientific managers and mentors scientists.
• Oversee the scientific design and development of new products and services to accelerate growth.
• Communicate results effectively to clients and develop lasting relationships to support future work
• Responsible for the operational management of the lab including inventory maintenance, instrument maintenance, capacity assessment, quality reviews, and any special projects such as LIMS development/ validation.
• Lead and participate in establishing growth objectives, goals, KPIs, policies, plans and programs
• Responsible for the overall weekly/ monthly revenue generation, tracking and reporting.
• Responsible for ensuring the scientific staff properly oversee ongoing client studies, ensuring timely reagent ordering, assay development or execution and data delivery.
• Interact, influence, and collaborate effectively with Precision colleagues and counterparts at other Precision labs.
• Effectively communicate our capabilities and offerings to the Precision customer community and develop new business opportunities through industry networking attendance and scientific meetings and client presentations
• Act as internal expert on technical advances and industry trends to anticipate and act as a thought leader to management on all matters of major importance, initiate and/or recommend appropriate courses of action and identify those matters requiring policy interpretation or revision
• Provide SME support for contract proposals, as appropriate
• Write and implement standard operating procedures (SOPs)
• Suggest / write publications and white papers on any new or novel technologies or assays.

Qualifications:

Minimum Required:

• Must have a Ph.D. in life sciences, expertise in tissue based or molecular assays
• At least 18 years of full-time post-doctoral laboratory experience and 10 years demonstrated management experience

Other Required:

• Strong bench scientist skills around tissue based (IHC, ISH, mIF) and / or molecular assays (ddPCR, qPCR, NGS)
• Experience in validation/qualification of assays to GCLP/CAP/CLIA/GLP or ISO guidelines
• Ability to lead and organize teams to multi-task and deliver projects according to agreed timelines
• Collaborative and an excellent coach and mentor
• Familiarity with current regulations regarding the FDA Good Clinical Laboratory Practices and the College of American Pathologists standards and accreditation requirements; various aspects of the FDA’s Modern Quality Systems thinking to include: Quality by Design and Product Development, Quality Risk Management, CAPA (Corrective and Preventive Action) and Change Control
• Experience leading or participating in a comprehensive quality systems (QS) model, highlighting the model’s consistency with the GCLP regulatory requirements
• Strong written and verbal communication

Preferred:

• Industrial (Contract Research Organization, CRO) experience and/or management of outside collaborations is desirable

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