Principal Scientist/Director - Oncology Companion Diagnostics
Principal Scientist/Director - Oncology Companion Diagnostics
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$ 153800 - 242200
1 Vacancy
Job Description
Job Description
In this Principal Scientist/Director position within Translational Oncology this team member will provide leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx) including associated digital pathology (DP) projects when applicable and execution of those strategies in collaboration with Product Development Teams (PDTs) Asset Development Teams (ADTs) and our diagnostic reports to Executive Director CDx.
Primary Responsibilities:
Direct CDx/IVD development projects including associated DP efforts when needed within Translational Oncology
Lead crossfunctional CDx (and where relevant DP) development teams for various assets/biomarkers (including Regulatory Commercial Business Development Project Management Operations Clinical Development Statistics Bioinformatics Alliance Management etc.) to drive the implementation of Dx projects and coordinate the work conducted with our external Dx partners.
Interface directly with scientists and physicians in discovery sciences earlystage clinical development and latestage clinical development as well as other PDT & ADT members to craft the project teams CDx (and associated DP if relevant) development strategy.
Lead the selection of appropriate assays and Dx platforms for the execution of biomarker strategies.
Lead digital pathology efforts as needed for each individual CDx project
Serve as a subject matter expert within our Company collaborating with project teams biomarker leads clinical operations and regulatory affairs on the implementation of global CDx assay strategies in global clinical trials.
Participate in preparation of Dxrelated regulatory documents including for example presubmissions briefing books IDEs IVDR PSAs PMAs.
Participate in meetings with global regulatory agencies to provide CDx expertise.
Provide CDx input into earlystage oncology programs.
Assist in the transfer of assays from inhouse efforts to in vitro Dx companies.
Provide CDx expertise/assessment for due diligence teams.
Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors.
Perform operational tasks required to execute assigned projects as needed e.g. ordering samples QC of incoming clinical trial biomarker results assay/data transfer troubleshooting etc.
Education Minimum Requirements:
MD/PhD MD or PhD
Required Experience and Skills:
Minimum of 5 years of experience in industry
Extensive experience with one or more major molecular biomarker platforms (i.e. NGS IHC PCR)
Knowledge of the discovery development and application of molecular biomarkers in support of decision making for drug development and as CDx
Demonstrated track record in the development of CDx
Demonstrated expertise in molecular diagnostic development as evident by peer review publication record patents and/or products
Experience influencing without direct authority navigating complex or matrix organizations and successfully networking and forming partnerships with crossfunctional teams.
Proven decisionmaking and planning skills
High level of verbal and written communication skills including presentation capabilities to senior executives
Preferred Experience and Skills:
Eight or more years experience in industry preferably in both pharma and Dx settings
Experience in development of digital pathology algorithms/assays
Experience with requirements for EU IVDR China HGRAC JPMA and other global markets for CDx development/registration
Experience directly interfacing in meetings and written documents with global health authorities
Deep technical knowledge in an area of interest such as circulating tumor DNA (ctDNA) immunohistochemistry / pathology digital pathology
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$153800.00 $242200.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
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Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/3/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
