US-MA, In situ Diagnostics Lab Director 213139BR-MZ
In situ Diagnostics Lab Director
Global Drug Development
Research & Development
The Oncology Precision Medicine (OPM) In situ Diagnostics Lab Director is responsible for directing the development of protein and nucleic acid based in situ hybridization assays used in clinical trials for exploratory purposes and potential IVD registration. The successful OPM In situ Diagnostics Lab Director will lead and oversee a team of scientists to implement all aspects of assay development including feasibility studies, transfer of assays to diagnostic partner, and analytical and clinical validation. Expertise in immuno-histochemistry and in situ assays is required.
1.Functionally and operationally reports to the Global Head of Immuno-Oncology Biomarker diagnostic Center of Excellence (IO-CoE).
2.Responsible for leading the development and validation of in situ hybridization and IHC assays including image analyses approaches and multi-analyte detection.
3.Responsible for leading the determination of appropriate cut-offs and interpretation algorithms associated with pathology review of IHC and ISH assays.
4.Responsible for managing all associates in the in situ Diagnostics Lab team and developing the career paths of principal scientists, senior scientists, and histo-technicians within the group.
5.Is the interface between the In situ Diagnostics Lab group and OPM IO Director, FPM and TPO directors. Will lead collaborative efforts between these team members and with both external partners (clinical research organizations, Academic Labs, clinical labs, pathologists, and diagnostic partners) and internal partners (TCO, NIBR, OTR groups).
6.Leads team in the identification and feasibility testing of future in situ hybridization based assays e.g. Leica and ACD RNA in situ tumor cell assay.
7.Accountable for the identification and validation of external in situ partners and laboratories involved in CTAs for clinical trials and companion diagnostic development.
8.Responsible for ensuring timely execution of protein and in situ assay development for FPFV in GDD trials involving patient selection, stratification, pharmacodynamics, correlative studies and CDx development.
9.Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission.
10.Leads the in situ lab to proactively identify, manage, and come up with solutions to potential risks in GDD program(s) that can impact both short term and mid-term programs.
11.Contributes to the development, implementation and continuous improvement of processes supporting the OPM vision, mission and goals.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
D.O., M.D., or Ph.D with ABPcertification.
Fluent English (written and oral),
1.5+ years of industry experience in in situ and IHC based assay development
2.5+ years multi/cross functional leadership experience within an Oncology business unit.
3.Proven people leadership capabilities in staff management role or in other organizational assignments.
4.Expert skills to facilitate/optimize contribution of team members as individuals and members of cohesive team.
5.Excellent interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
6.Outstanding verbal and written communications.
7.CLIA laboratory/IVD development experience is an advantage
9.Board certification or eligibility for board certification is an advantage
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.