Principal Scientist, Clinical Development

About The Job

The Principal Scientist, Clinical Development is responsible for developing complex high priority clinical utility and validity evidence to support Clinical Development Plans and ultimately FMI products and biomarkers. This individual fills a highly visible role on the Foundation Medicine (FMI) Clinical Development team, partnering closely with Research & Development, Biopharma, Product/EBT, and Clinical Operations to design and execute studies to address clinical and business needs. This position also requires significant biomarker, diagnostic and oncology subject matter expertise and is involved in driving the clinical development of new biomarkers and products throughout the whole lifecycle management, and working in close collaboration with cross-functional teams to advise on product development and validation strategy through reporting, reimbursement and launch. This individual manages or mentors other scientists and directly support interactions with commercial and medical partners and collaborators towards securing new partnerships. This position supports product and biomarker evidence generation activities including new biomarker and product evaluation and development.

Key Responsibilities

• Continually develop deep domain expertise in genomics from a scientific, clinical and technical standpoint and lend insights and early clinical evidence to cross-functional teams to further FMI and Clinical Development strategy, and development and validation of our products and biomarkers.
• Contribute to the development and refinement of clinical development strategies and plans, providing support to clinical development leads in their execution and decision-making.
• Contribute to protocol and SAP design and review for studies led by Clinical Development.
• Leverage FMI’s clinical and genomic datasets to link genomic findings with clinical outcomes.
• Ensure studies advance the strategic priorities of FMI products.
• Lead key manuscripts from initial concept to publication to establish clinical validity and clinical utility of our products.
• Contribute broadly to the conception and execution of conference abstracts and publications.
• Manage and establish beneficial collaborations with key opinion leaders in oncology, including academic scientists, oncologists (or other specialties), and biopharma partners
• Maintain availability to the wider FMI business for clinical development expertise, presenting information and evidence to scientific, medical, legal, commercial, or other stakeholders.
• Manage or mentor/motivate other scientists as well as directly support interactions with collaborators towards securing new scientific partnerships.
• Other duties pertinent to clinical / translational science as assigned.
  
  

Qualifications

Basic Qualifications:

• M.A., in a life sciences or bioinformatics
• 10 years of experience in data science, genomics, translational oncology, or clinical outcomes research clinical research in an academic or life sciences industry setting
• Proficiency with one or more script languages (Python, Perl, etc.) and statistical software package (R, SAS)
  
  

Preferred Qualifications

• Demonstrated experience designing and executing analysis in the field of cancer biology and genomics
• Strong expertise leading biomedical data analysis (genomics data, clinical outcomes, real-world data, blood biomarkers i.e. circulating tumor DNA, RNA, gene and protein expression)
• Experience leading multiple projects simultaneously, communicating with internal and external stakeholders, building narrative, incorporating feedback, and responding to business needs
• Experience with clinical trials and companion diagnostic development
• Experience with oncology diagnostic development and product development and validation
• Demonstrated ability to successfully manage multiple concurrent projects in a fast-paced, dynamic environment
• Strong publication record and track record of taking projects from concept to completion
• Familiarity with analyzing blood biomarkers such as circulating tumor DNA to support innovative diagnostic applications
• Ability to work independently as well as collaborate and communicate effectively with cross-functional teams
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, creativity, and problem solving with other departments and colleagues
• Excellent organizational skills and meticulous attention to detail
• Extremely high level of integrity and reliability
• Willingness to adhere to all applicable FMI Standard Operating Procedures, policies, processes, and compliance guidelines
• Understanding of HIPAA and the importance of patient data privacy
• Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information
• Commitment to reflect FMI’s values: Integrity, Courage, and Passion