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Principal-Sr. Principal Scientist, PK/PD Modeler

Cambridge, MassachusettsFull-time
About the Job
A unique opportunity to become an integral part of a rapidly emerging Immuno-Oncology, Auto-Immune and Infectious Disease company. HIFIBIO Therapeutics is seeking a motivated, independent, dedicated, and flexible DMPK/Pharmacometrics professional who will thrive in a fast-paced dynamic company with unique potential biomarker-technology, best in class therapeutics, and a global footprint. The successful candidate will deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables, inform internal decision-making, and strengthen regulatory submissions.  You will have the opportunity to work transversally across all HiFiBiO projects and sites (US, France and China) in close collaboration with Project Leaders, in vivo Pharmacology and Clinical Research experts to lead the DMPK related activities for the company’s immune-therapeutic antibody programs through pre-IND, IND filing and clinical development stages.

Primary Responsibilities
  • Engage and lead the DMPK activities to characterize the ADME properties of our antibody candidates. 
  • Participate in the design and interpretation of in vitro and in vivo studies needed to predict and recommend starting and efficacious doses and schedules in humans. 
  • Support an expanding Clinical Research team, lead the design and implementation of Pharmacometrics strategy at the program level, and be a core member of R&D driving innovative new projects in Immuno-oncology, Auto-Immune, and Infectious Diseases.
  • Take responsibility for effective planning, performance, and interpretation of regulatory ADME studies and the preparation of the IND and other regulatory submissions’ DMPK related modules. 
  • Coordinate internal/external resources and third parties for timely study execution and data delivery by developing a detailed project DMPK plan to ensure the translatability of preclinical animal data to humans. 
  • Support quantitative decision-making through the development and application of population PK, PK/PD, exposure-response and other models in multiple therapeutic indications.  
  • Responsible for the construction, validation, and implementation of disease, placebo, exposure-response, and mechanistic PK/PD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with R&D partners.
  • Involve and ensure communication and alignment between all relevant stakeholders for technical feasibility, resource availability and proper allocation, and to monitor and track progress.
  • Contribute to creating an open and collaborative working environment driven by common goals and competitive timelines.

Requirements
  • An M.S. Degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences or PharmD with a minimum of five (5) years of pharmaceutical development experience with at least three (3) years of relevant experience performing progressively advanced duties at the Senior Scientist level.
  • OR, PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences or MD with a minimum of four (4) years of pharmaceutical development experience with at least 3 years of relevant experience performing progressively advanced duties at the Senior Scientist level. 
  • Must be an expert in PK/PD modeling, , dose-response and exposure-response analyses and human dose projections.. Expertise in applied Population PK, PK/PD, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling to support drug development is a plus.
  • High proficiency in PK/PD and statistical software (e.g., NONMEM, WinNonlin, R or other relevant software tools).
  • Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings preferred.
 
Additional Experience and Skills Preferred
  • Successful track record in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting, whether in academia or industry.
  • Advanced knowledge in the use of MS Project, MS Excel &/or other Project Management/ tracking tools.
  • Demonstrated ability to leverage relationships and networks to enhance team dynamics and proactively identify and remove obstacles to drive business results.
  • Strong collaboration and problem-solving skills to establish good working relationships with employees at all levels, to influence decision-making, provide feedback, devise and implement creative solutions to problems.
  • Independently perform analysis, modeling and development of reports with limited supervision.
 
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.