Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Senior Scientific Director?

 

Position Summary:

The Senior Scientific Director, Cellular Assays will use their scientific expertise to lead development and validation efforts for bioanalytical assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research.  As a team leader with direct reports, the person will train and mentor staff to ensure scientific rigor and use their expertise to guide assay development and troubleshooting.  The position requires direct experience in all aspects of regulated and non-regulated cellular assays and must have working knowledge of all current regulatory guidance and industry best practices. The person will also engage with QA to maintain regulatory compliance and work with project managers ensure timely and efficient client communication. Lastly, ideal candidate will have had experience with hosting and/ or participated in regulatory audits.

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

As Head of laboratory this position is fully responsible for all scientific activities, regulatory compliance, staff, and metrics associated with clients and product delivery. Mentor and lead all scientific staff assigned to cellular assays. Ensure proper method development and validation of projects so they are quality driven and executed against communicated timelines and milestones. Direct scientific staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects and client studies. Participate actively in the Cellular community to ensure Precision is fully aware of any all-relevant guidance for regulations pertaining to Flow Cytometry, ELISPOT and other cellular biomarkers. Serve as Technical Lead (Subject Matter Expert) for all Cellular Assay Projects. Serves as Project Director or Principal Investigator as required. Lead the scientific team in the design and execution of all experiments, ensure all data is accurately analyzed, quality driven and delivered to clients on time. Communicate clearly (written and verbal) and often with clients and ensure product delivery is within client expectations for all projects associated to cellular assays. Lead the team in establishing, writing, reviewing and/or improving all procedures (SOPs POPs), study Protocol/plans, assay validation/verification and associated reports. Identify, update and implement emerging laboratory techniques and/ or instrumentation. Work collaboratively with other technical teams in resource sharing and providing technical expertise. Write and prepare abstracts, techniques/or draft scientific papers to maintain the scientific standard and image of the company. May present completed work at appropriate scientific meetings and in publications. Responsible for trouble shooting and correcting routine scientific issues/problems in a timely manner. Act as a scientific resource externally to clients and internally on Product and Services/ R&D related projects Assist with writing, reviewing and editing contract and grant applications/proposals as appropriate Maintain and support safe lab practices and environment Carry out other duties/projects as assigned

 

Qualifications:

Minimum Required:

D. in life sciences or relevant field in life sciences and at least 10 years of full-time relevant laboratory experience or equivalent combination of education and experience. Prior management experience. A solid understanding of current GxP or CAP/CLIA/ISO standards Previous work experience in GLP or GCLP or CLIA regulatory compliance

Other Required:

Expert level mammalian cell culture and plate-based cellular assay experience Ability to troubleshoot and refine cellular assays such as NAb and ELISpot measurement. Experience in handling various sample types such as plasma, serum, and PBMCs Excellent communication, interpersonal, and organizational skills required. Must have the ability to organize and analyze data, as well as prepare reports Must possess strong computational skills, preferably experienced with Word, Excel, Power Point, Gen5 and GraphPad Prism Excellent use of judgment and discretion required. Extended work hours may be occasionally necessary in order to meet business demands. Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) Must be able to read, write, speak fluently and comprehend the English language.

Preferred:

A solid understanding of current method validation standards Experience supervising or mentoring scientists or technical personnel. A solid understanding of current GxP or CAP/CLIA/ISO standards Previous work experience in GLP or GCLP or CLIA regulatory compliance