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Senior Principal Scientist/Associate Director, Clinical Biomarker Discovery and Development

Cambridge, MassachusettsFull-time
About the Job
Sr. Principal Scientist/Associate Director - Clinical Biomarker Discovery and Development

About the Job:
As the Principal Scientist / Associate Director Clinical Biomarker Discovery and Development you will impact the clinical development of HiFiBiO’s novel immunomodulatory antibodies by leveraging insights from its proprietary Drug Intelligent Science (DIS™) single-cell immune profiling platform. You will lead the discovery and clinical implementation of pharmacodynamics and predictive biomarkers that will be deployed in an early clinical trial, as well as the development of companion diagnostics with a strong focus on solid tumors.

Primary Responsibilities:
  • Prioritize and address key translational questions by developing experimental plans and overseeing internal and contract research organizations for the analyses of biomarkers in patient samples, including the use of commonly evaluated readouts in the field as well as developing novel biomarker approaches.
  • Exhibit strong scientific and strategic leadership through developing and executing translational/clinical biomarker strategies. 
  • Influence and inspire scientists in the organization, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
  • Serve as the clinical biomarker lead and coordinate activities for all our programs.
  • Remain current on cutting-edge technologies, both for the internal and external technology platforms, and help educate the wider scientific community at HiFiBiO.
  • Perform evaluation and selection of adequate technologies for the establishment of clinical biomarker assays that meet clinical laboratory standards and regulatory requirements.
  • Provide technical and scientific leadership throughout different phases of assay development and validation.
  • Lead the establishment and development of DCx platform by managing external vendors for timely delivery of high-quality clinical data within the required clinical study timelines.
  • Applies the highest scientific and technical standards for the successful design and execution of clinical assays implemented in clinical programs.
  • Collaborate with computational scientists and statisticians to perform data mining and interpretation and present the data in project team meetings.
  • Build relationships and collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities.

Qualifications:
  • Ph.D., MD, or MD/Ph.D. in biology, pharmacology, or related discipline with 2-5 years of post-doctoral experience.
  • Track record of sustained, significant scientific contributions as demonstrated by publications, patents, and presentations.
  • Experience in advancing molecules from preclinical to Phase I and to Phase II, ideally with experience in implementing biomarkers for patient stratification.
  • Subject matter expert in Oncology, preferably Immuno-oncology, knowledgeable about other therapeutic areas for instance autoimmune diseases.
  • Subject matter expert in the development and validation of clinical-grade assays, as well as, assays using various advanced technologies that may not be currently in clinical use. CLIA lab experience is a plus.
  • Strong scientific background and experience with assay development and validation.
  • Experience in authoring relevant sections of clinical and regulatory documents for biomarker development.
  • Strong communication skills, ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments.

To Apply:
Please send a cover letter and CV briefly stating why your skills set would suit the job and your reasons for applying to the posting found on our career page at www.hifibio.com.  All CVs will be evaluated at our earliest availability.
About HiFiBiO Therapeutics

HiFiBiO Therapeutics is an emerging multinational company mobilizing the human immune system to combat disease and transform patient care. We integrate deep-rooted biological expertise, apply advanced single-cell profiling technologies and leverage open-innovation strategies to accelerate the development of a repertoire of innovative antibody drugs to treat cancer and autoimmune disorders.