Associate Director / Director, Clinical Biomarker Lead
Cambridge, MA, USA
Posted on Thursday, September 7, 2023
Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.
We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.
Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.
Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.
As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.
Cullinan Oncology is seeking an experienced Biomarker and Translational Sciences leader to join the Translational Research team. A successful incumbent would help integrate basic science research, proteomics, genomics and informatics to move programs into the clinic as well as leverage clinical findings to identify biomarkers and novel discovery opportunities for Cullinan’s extensive immune oncology pipeline.
This role will be hybrid, with 1 day on-site at our Cambridge, MA location.
- Work closely with the preclinical group to define translational hypotheses, including potential pharmacodynamic and predictive biomarkers for novel immune oncology targets.
- Design and implement bioanalytical, clinical biomarkers and exploratory translational strategies; adhere to clinical and regulatory submission protocols.
- Successfully manage CROs and establish relationships to develop bioanalytical and biomarker assays, monitor assay qualification/validation at CROs, as well as bioanalytical/biomarker testing in the clinic.
- Collaborate with clinical operations and the central lab to develop appropriate clinical laboratory manuals and to support sample management and logistics.
- Perform integrative analysis of flow cytometry, gene expression, IHC/MultiplexIF data, and drug response data for baseline and post-dose biomarker discovery for clinical programs.
- Drive decisions to support PK/PD and predictive biomarker analysis in clinical studies.
- Ensure quality and timely submission of all clinical biomarker -related documents and materials for regulatory filings, including scientific advice filings, INDs, meeting briefing books, and other requests from global regulatory authorities.
- Ph.D. in Immuno-oncology, Immunology, Cancer Biology, or related field and 5 or more years of industry (biotech/pharmaceutical) clinical biomarker experience.
- Deep understanding of the pre-clinical, translational, and clinical stages of drug development in the immune-oncology field.
- Extensive working knowledge of biomarker and bioanalytical assay development and cutting-edge Omics methodologies in the clinic.
- Hands-on experience with flow cytometry data analysis in clinical trials is required.
- Experience leading within and collaborating effectively as a member of a cross-functional team.
- Demonstrable knowledge of appropriate quality standards including ICH/GCP, and global regulations.
- Experience in selection and management of external CROs.
- Excellent analytical skills, with an ability to communicate complex issues in a simple way.
- Ability to be agile and drive data-based decisions.
Cullinan Oncology is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.