Senior Scientific Director

4 weeks ago

Frederick, Maryland, United States Precision for Medicine Full time
Senior Scientific Director Job Description

Precision for Medicine is a global precision medicine clinical research services organization, dedicated to improving the clinical research and development process for new therapeutics. Our approach integrates clinical operations excellence, 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 a focus on oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we are committed to accelerating life-changing treatments globally.

Job Summary:

The Senior Scientific Director will lead the development and validation of 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 guide assay development and troubleshooting. The position requires direct experience in all aspects of regulated and non-regulated cellular assays and a working knowledge of current regulatory guidance and industry best practices.

Key Responsibilities:
  • Lead the scientific team in the design and execution of all experiments, ensuring all data is accurately analyzed, quality driven, and delivered to clients on time.
  • Communicate clearly (written and verbal) and often with clients, ensuring product delivery is within client expectations for all projects associated with cellular assays.
  • Develop 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.
  • Present completed work at appropriate scientific meetings and in publications.
  • Responsible for troubleshooting 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.
Qualifications:
  • 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.
Preferred Qualifications:
  • 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.

Precision for Medicine 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. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please contact us at [insert contact information].

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