Associate Director, Companion Diagnostics
Proclinical is seeking an Associate Director of Companion Diagnostics for a global biopharma company specializing in the developing of immuno-oncology treatments. As the Associate Director, you will be part of the Diagnostic team, supporting Compound Development teams and Brand teams by providing evaluation, strategy, development, and implementation of diagnostic tests in support of an established clinical portfolio.
- Represent Diagnostics Team on select translational research teams and compound development teams in enabling personalized healthcare for therapeutic programs.
- Collaborate with key stakeholders, including, but not limited to, Discovery, Translational Research, Clinical Research, Regulatory and Commercial teams to develop a diagnostic strategy to enable registration of a pharmaceutical asset alongside a diagnostic product.
- Interact with Translational Research teams to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal research capabilities to develop, validate, and implement a predictive assay if not already available.
- Working closely with translational research and biomarker operations team to select contract laboratory for testing predictive assays in early clinical development. Help oversee assay transfer to contract laboratory and ensure proper assay validation by working with subject matter experts within the department.
- Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements.
- Regularly communicates updates to, and seeks feedback from, Clinical Teams, Compound Development Teams, and other stakeholders where appropriate, surrounding progress of the companion diagnostic program.
- Keep current with novel technologies that have impact on oncology diagnostic testing. Aid in selection of diagnostic assay methodologies. Help map marketplace on optimal technologies/platforms and use strategic considerations in choosing a diagnostic partner.
- Lead the development of single-plex/multiplex assays, including novel technologies, to support investigational and approved products in collaboration with diagnostic partners
- Coordinate all executable activities between development teams and external diagnostic partners ensuring alignment of companion diagnostic development milestones with clinical milestones by developing/tracking timelines, budgets, and resources towards ensuring delivery of critical milestones from diagnostic partner and provides timely updates to relevant functional teams regarding development status.
- Provide internal and external subject matter expertise for precision medicine activities by acquiring and disseminating precision medicine knowledge to key stakeholders.
Skills and Requirements:
- PhD (preferred) in Life Science or equivalent M.S. degree will be considered for exceptional candidates.
- 5+ years' experience in assay and IVD development, with broad understanding of design control process, analytical and clinical validation, manufacturing, GCP, GLP, and GMP requirements, US and global regulatory submissions (Pre-Subs, IDE, PMA), and commercialization of diagnostics.
- Demonstrated matrix leadership skills and ability to work effectively across multiple disciplines internal and external to the organization, with a track-record of successfully managed Diagnostic projects and success in working with multiple cross-functional teams.
- Broad knowledge and understanding of established and novel assay technologies (e.g., IHC, digital pathology, PCR, NGS, liquid biopsy, imaging).
- Broad knowledge of the drug development process (clinical trials, efficacy endpoints, biomarker testing).
- Collaborative, positive, open, and objective mind-set with critical thinking skills.
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.