Allogene is seeking a Director, Translational Science to craft and execute the biomarker strategy for one (or more) of the pipeline assets for clinical stage programs. The ideal candidate is an individual seeking challenges in a fast-paced and dynamic start-up environment. This individual will be responsible for supporting clinical programs, analyzing data in conjunction with BioMetrics and Bioinformatics, and collaborating with research and manufacturing teams.
Responsibilities include, but are not limited to:
- The candidate will be the lead Translational Scientist for clinical programs with multiple studies and will work under the Asset and Clinical Team structure in charge of the global program(s)
- This role oversees pharmacodynamic, mechanism of action/resistance, patient selection, and other clinically relevant biomarker studies through external CROs
- He/she undertakes cross-functional engagement with clinical science and clinical operations for implementation of biomarker analyses in the clinic
- He/she will ensure the output of the biomarker plans meets established program standards (within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline progress without compromising quality.
- To achieve these goals, the candidate will partner with internal functions such as biomarker operational management, labs for biomarker assay development and clinical bioanalysis, biostatistics, bio-informatics experts and clinical stakeholders.
- He/she will lead the clinical biomarker sub team, a matrixed group of subject matter experts.
- He/she will lead drafting of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
- As appropriate, he/she will provide biomarker expertise to progress validated biomarkers into development of pharmaco-diagnostic tools.
Position Requirements & Experience:
- PhD or PharmD Degree with a minimum of 5 years related industry experience in cancer immunology, a background in clinical pharmacology is a plus.
- Prior experience authoring clinical study or regulatory documents
- Prior experience developing & executing translational science biomarker strategies
- Excellent understanding of clinical development and clinical operations
- Must be able to collaborate and work with other departments such as Clinical, Commercial, Finance, Research & Development, Manufacturing, and Supply/Purchasing
- Ability to work in a fast-paced, start-up environment
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.