Job Title: Director, Companion Diagnostics

Department: Clinical Sciences

Location: Remote US

DIRECTOR, COMPANION DIAGNOSTICS

Overview of Role:

The Director, Companion Diagnostics is an exceptional scientist with extensive experience in global companion diagnostics with logistical skills to accelerate bispecific immunotherapy development. This role will support the companion diagnostics (CDx) strategy, managing the development and validation of CDx and ensuring global regulatory requirements are being met.

Role and Responsibilities:

• Develop, formulate and execute on clinical study companion diagnostics (CDx) strategy in immunotherapy and angiogenesis blocking biologics in various solid tumors aligned with program goals
• Map and plan out in detail the logistical needs to implement companion diagnostics (CDx) strategies during global clinical study synopsis conceptualization.
• Working with Clinical Operations and other cross-functions, lead identification, evaluation, communication and selection of CDx diagnostic vendors/CROs with global footprint
• Oversee and manage the development and validation of CDx and ensure global regulatory requirements are met
• Review, articulate, and respond to biomarker queries in regulatory documents from global health authorities with sense of urgency
• Provide clinical summary of drug programs under clinical development in lung cancer and other diseases
• Contribute to clinical studies of immunotherapy conducted by CROs including vendor selection, initiation/planning, study design, writing protocol/report and managing budget
• Contribute to other preclinical and research programs as needed
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• BS required; PhD (preferred)
• Minimum of 10+ years working experience in pharmaceutical or biotechnology industries with a minimum of 5+ years of experience working on Companion Diagnostics in oncology drug development and clinical operations
• Strong understanding of global regulatory pathways and future trends for CDx assays
• Strong understanding of clinical operations and implementation of companion diagnostic assays in oncology clinical trials
• Strong scientific understanding/experience of biological basis of immunotherapy, angiogenesis pathways. Solid biochemical understanding of biologics and therapeutic drugs.
• Strong understanding of biomarker assay qualification, analytical validation in companion diagnostic development
• Strong ability to work well in a fast-paced environment cross functional environment
• Strong organizational and presentation skills mandatory

The pay range for this role is $186,000 – $233,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

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