Careers

Associate Director, Translation - Clinical Development

Location: Cambridge, MA

POSITION

In this position within the clinical development function, the candidate will develop and implement biomarker assays for pre-clinical and clinical stage programs, helping to identify potential MOA, patient stratification, PD, efficacy biomarkers.  The candidate will also contribute to (assist the clinical lead in) the clinical development plans, including evaluation of translational medicine and biomarker strategy, discussions with clinical investigators and advisors and contingency planning. The candidate should have proven bench level expertise in establishing and performing a wide range of molecular and protein-based assays. The candidate will also be responsible for guiding and overseeing CROs for multiple projects, including overseeing internally developed assay transfers if required. Keeping the company up to date with the latest tools and platforms for both protein/nucleic acid-based markers will also be the candidate’s responsibility. This position offers the opportunity to contribute to both drug discovery and clinical projects in an innovative and fast-paced team environment with tremendous growth opportunity.

ESSENTIAL FUNCTIONS AND DUTIES

  • Serve as biomarker/CDx lead for drug discovery and development projects.
  • Develop and deliver the biomarker strategy and translational science plan to support evidence of drug-target inhibition in early clinical trials and enable clinical decision making.
  • Help author and review the clinical protocol, study design, amendments, IB, clinical sections of IND/IMPD and CTAs filings under the guide of the program lead.
  • Works alongside clinical operations to ensure study design feasibility and for deployment of PD and patient selection assays, lab manual, clinical sample handling logistics.
  • Manage outsourcing of clinical biomarker assays.
  • Perform biomarker profiling in-house for pre-clinical experiments.
  • QC/QA of data generated by CROs plus internal clinical sample profiles.
  • Serve as a “technical expert” to outside functional areas for all biomarker/platform related topics in addition to performing platform evaluations and recommending new technology uptake, consistent with program needs.
  • Author and review clinical abstracts, presentations for conferences when appropriate and assist with writing and managing manuscripts for completed studies.
  • Excellent oral and written communication skills.
  • Great interpersonal and organizational skills.

SKILLS AND EXPERIENCE

  • PhD with 5+ years of industrial experience in relevant scientific area, e.g. Oncology, Pharmacology, Molecular biology
  • Prior experience as biomarker/translation lead for clinical/lead programs
  • Recognized expertise in Biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or external presentations
  • Experience with protein, molecular and cell-based assay development is required.
  • In-depth knowledge of molecular biology plus NGS experience is highly desirable.
  • Proven ability to work independently and design experiments, troubleshoot, interpret and report data.
  • Highly analytical mind, attention to detail, and organization skills are critical.
  • Collaborative and proactive attitude with excellent written and oral communication skills.
  • Embodies Kronos values; exhibits high degree of integrity and professionalism when interacting with outside investigators and vendors.
  • Entrepreneurial and enjoys working in a fast-paced, creative and resourceful small company environment.

To apply for this position, please forward your resume and cover letter to careers@kronosbio.com.