Assistant Director, Translational Science

Company Description

Star Therapeutics is a Phase 3 clinical stage biotechnology company that aims to discover and develop best-in-class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top-tier biotech investors. We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.

Role Description

We are seeking an Assistant Director of Translational Science for a full-time hybrid role based in South San Francisco, CA, with an option for partial remote work. In this role, you will 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. 

Qualifications

• Ph.D. and 8 years of experience or Masters and 12 years of experience required
• Experience working on clinical teams in the development of drug candidates (early and/or late clinical studies are both of value)
• Experience in project leadership and a track-record of authoring translational clinical study reports for clinical studies with particular focus on regulatory filings.
• Experience in supporting regulatory interactions as a subject matter expert for Translational Medicine in collaboration with clinical and regulatory affairs team members
• Candidates with extensive experience developing and managing relationships with toxicologist and clinical pharmacologist are encouraged to apply.
• Strong scientific background in key disease areas or evidence of broad work in multiple disease areas displaying adaptability in learning new indications
• Ability to interface in collaborative clinical development teams, including with key interactions with bioanalytical, clinical pharmacology and clinical sciences.
• Strong technical and scientific writing skills to deliver key data summaries and documents
• Ability to review and contributions to clinical study protocol development on behalf of translational medicine organization.
• Familiar and adept in knowledge across a wide range of data workstreams for PK, PD, biomarker and immunogenicity assessments. 
• Biomarker and PK/PD data analytics with integrated data analysis
• Technical document writing and review in creation of clinical study reports, SOPs, and regulated documents, with ability to work within GXP guidance
• Preparation of slide presentations and documentation for regulatory agency interactions
• Project management, including balancing competing timelines across multiple programs
• Ability to work in a fast-paced environment requiring flexibility and clear communication

NO PHONE CALLS or AGENCIES, please.

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