Associate Director, Translational Science

Associate Director, Translational Sciences

Reports To:

VP, Translational Science Department:
Translational Science

ABOUT THE JOB

This is a full-time role requiring presence in the South San Francisco, CA office at least 1-2 days per week, with the flexibility to work from home part-time. The Associate Director, Translational Science will report to the VP of Translational Science and work closely with members of the translational, research and clinical teams. The role has an individual contribution focus on the translational medicine work in the ongoing clinical development of leading drug candidates for the company.

The central responsibilities for the role are in assisting the development and implementation of a translational medicine strategy for PK, PD, biomarker and immunogenicity assessments along with a key role in the subsequent data analysis and the writing of translational study reports in support of translational work for clinical studies.

As an Associate Director, the candidate is expected to represent translational sciences as a translational medicine lead for clinical studies and work closely with the clinical development team members including bioanalysis, clinical operations, regulatory affairs, quality, medical writing, safety, clinical research and clinical leadership. Knowledge of regulatory requirements for translational medicine research and experience in generating and guiding document preparation, analytical plans and contributions to the translational medicine components in clinical study protocols is required.

A current understanding of industry guidance for regulated bioanalysis in preclinical and clinical is needed. The role will require the candidate to work closely with clinical pharmacologist and clinical scientists to achieve key deliverables. Prior experience in documentation preparation (including clinical study memos, BLA or IND documents) for regulatory interactions with both the FDA and potentially global regulatory agencies is of high value to a candidate’s application.

This role provides additional opportunities to participate in a preclinical team environment as a contributor towards IND enabling translational research studies, particularly in cynomolgus studies for PK/PD, dose range finding and GLP tox studies.

Prior experience in working with toxicologist or outsourcing with toxicology consultants is beneficial, with experience in authoring internal reports and contributing to regulatory filings as value added. As part of the collaborative research team role, the candidate is expected to work with individuals across research and translational research groups, including discovery research, drug development and protein sciences, preclinical bioanalysis and other junior staff within translational research organization.

OUR CORE VALUES

The below core values drive all that we do here  are looking for like-minded individuals that feel passionately about these same values to join our team.

• Patients are our Center of Gravity:
  We partner with patients in unique ways, to uncover and address their unmet needs.
• Propelled by Data, Guided by Intuition, Informed by Expertise:
  We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
• Mission Ready Crew:
  With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.

RESPONSIBILITIES

• Primary interface and translational medicine lead in support for clinical teams for Phase 1 through Phase 3 clinical studies, and potentially during lifecycle management.
• Oversee translational medicine strategy planning and implementation during clinical trials
• Data analysis, data review, data interpretation and data delivery in support of regulatory filings within program timelines for translational datasets
• Prepare translational medicine study reports for incorporation into clinical study reports and preparations for regulatory interactions and filings
• Capture and communicate clinical development team needs to the translational research team in support for clinical programs
• Provide expertise and guidance for translational medicine strategy…