Associate Director, Precision Medicine & Companion Diagnostics

Required Skills, Experience and Education

• Lead the development and implementation of diagnostic strategies through registration and launch for individual clinical studies and/or molecule programs.
• Direct the development, outsourcing and validation of clinically applicable in vitro diagnostic assays through the development lifecycle of molecules, including design, implement and oversee diagnostic testing and registration strategy and timely communication with key internal and external stakeholders.
• Provide expertise to development project teams to ensure access to state-of-the-art approaches on appropriate diagnostic technologies (e.g. NGS-based tissue and ctDNA assays, PCR, immunohistochemistry), evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed companion diagnostic assay.
• Oversee implementation of clinical trial assays at CRO laboratories for centralized testing supporting clinical trials.
• Maintain oversight of all scope or changes in study are timely implemented, including the development of the work order, costs and agreements.
• Lead joint development teams between RevMed and Dx partners to ensure cross-functional alignment of overarching development, regulatory and commercialization strategy, successful fit for purpose CDx development and that co-development timelines are met.
• Serve as subject matter expert in diagnostic regulation and support the interactions with global health authorities regarding companion diagnostics development and submissions.

Preferred Skills

• Highly experienced biomarker or diagnostics professional (MS and/or PhD) with a minimum of 7-10 years of relevant industry experience with expertise in oncology biomarker and/or companion diagnostic development.
• High level of initiative and ability to work independently with business awareness, hands on experience in IVD development processes and global in vitro diagnostic regulatory aspects related to companion diagnostic development.
• Experience with biomarker application in clinical trials and awareness of the challenges of implementing diagnostic technologies in the clinical setting.
• Experience with health authority interactions and regulatory submissions for pharmaceutical and/or in vitro diagnostics development globally.
• Excellent leadership skills including motivation and influencing without authority.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders with excellent communication, analytical and organizational skills.
• Cross-functional experience in commercial and or medical aspects of companion diagnostics is a plus.

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $186,000 - $233,000 USD.