Senior Director, Translational Sciences

Position Details

Date Posted:

June 22, 2020

Location:

Cambridge, MA

Description:

The Senior Director, Translational Sciences is a highly collaborative role that will be responsible for developing, implementing, and executing cross-functional activities to bridge preclinical and clinical development programs in order to support drug development. This individual will be responsible for implementing an innovative immunometabolism-based biomarker strategy, supporting precision medicine initiatives, and prioritizing patient sample collections for  drug discovery programs. The successful candidate will effectively interact with project teams, clinical research physicians, CROs, academic experts, and internal scientists to deliver science that supports the development of future medicines.

Responsibilities

  • Lead development and implementation of target-specific translational strategies (e.g. mechanisms of drug efficacy, mechanisms of resistance, rational combinations, new indications, patient segmentations, and product differentiation)
  • Development and delivery of biomarker strategy including protocol development, translational plans, and study conduct including ownership of quantity and quality of biosamples
  • Work closely with leadership to develop, manage, and deliver translational research timelines, budgets, metrics, and milestones
  • Design and execute translational research plans supporting development programs at Rheos
  • Analyze biomarkers for Rheos by working with relevant functions and CROs; responsible for creating SOWs and interfacing with CRO for execution of services
  • Evaluates CROs for assay and data analysis capabilities
  • Travel to scientific meetings, advisory boards, CRO’s, and other sites as required
  • Author study reports, biomarker components of clinical protocols, patent applications, regulatory submissions, and peer-reviewed publications  
  • Contribute to the preparation of documentation required for regulatory submissions including INDs and NDAs  

Requirements:

  • MD-PhD or PhD in life sciences or medical sciences
  • A minimum of 10 years of biotechnology or pharmaceutical industry experience, with 5+ years in clinical development.
  • Experience supporting successful IND and NDA submissions, as well as, biomarker strategy and clinical sample acquisition required
  • Successful experience working in a highly cross-functional environment both with internal experts and external collaborators
  • A rigorous scientist with a track record of effectively and clearly impacting drug development
  • A history of demonstrated innovation in the translational space
  • Understanding of drug discovery and development, especially the transition from discovery research to the clinic
  • Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation, and genetic analysis platforms
  • Knowledge of GLP, assay validation methodologies, and regulations that apply to clinical laboratory studies that support regulatory submissions is desirable
  • Comprehensive knowledge of immunology and autoimmune disease. Working Knowledge of cellular metabolism, a plus. Appetite to develop metabolism-based biomarkers, essential.
  • Independent, scientifically directed, and innovative thinker
  • Ability to manage scientific collaborations and contracted research
  • Detail-oriented, with the ability to identify and implement creative solutions
  • Familiar with industry trends and current scientific thinking
  • Can-do attitude with effective collaboration skills