Manager / Sr. Manager, Companion Diagnostics & Translational Medicine

Array BioPharma - Boulder, CO3.4

Full-timeEstimated: $110,000 - $160,000 a year
EducationSkills
Company:
Array BioPharma is a biopharmaceutical company headquartered in Boulder, Colorado, with locations in Cambridge, MA and Morrisville, NC. Array is focused on the discovery, development, and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. We are a fully integrated, commercial biopharmaceutical company and received our first approval in late June.

Summary:
Directs and develops clinical biomarker research and companion diagnostics for novel and established cancer treatment regimens. Drives integrated strategic and operational plans for oncology drug/diagnostic co-development programs and ensures organizational alignment and seamless execution.

Responsibilities:
Part of the CDx & TM Leadership team responsible for defining and positioning oncology portfolio in collaboration with colleagues in research, clinical development, and marketing
Biomarker lead for clinical trials in oncology from candidate nomination (pre-IND) through proof-of-concept including:
Describing the clinical development strategy and patient selection criteria
Design, implementation and analysis of biomarkers in clinical trials
Translational lead on cross-functional development project teams
Close liaison with Discovery and Development teams for defining clinical biomarker approaches (e.g. prognostic, predictive, pharmacodynamic biomarkers)
Lead the development and implementation of companion diagnostic strategies, including co-development with in vitro diagnostic partners through Pre-Market Application (PMA) approval of the device
Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents as appropriate
Key resource for disease area expertise supporting Discovery and Development teams
Participate in formulating disease area strategy for target selection and validation
Function as a scientific and business thought-leader internal and external to the company and a key contact to external community
Ensures that vendors and laboratories are compliant with company and regulatory requirements

Requirements:
8+ years of relevant experience. Advanced degree (Ph.D.) strongly preferred.
Excellent leadership, organizational, written and presentation skills working in a matrixed team environment
In-depth experience in the discovery, validation and clinical implementation of innovative biomarkers and companion diagnostics

Required Specialized or Technical Skills:
Demonstrated application of expertise to discovery research through clinical development - preferably in oncology
Familiarity working with diagnostic companies, clinical laboratories, contract research organizations and academic collaborators
Familiarity with data management and visualization tools and collaborating with computational biologists to analyze complex genomic data sets emerging from clinical trials
Comfortable in a results-driven, highly accountable environment
A team asset and mentor who listens effectively, invites response and discussion and promotes creative problem solving
Strong business focus and an appreciation for internal and external business conditions that can impact decisions

Preferred additional experience:
Project management
IVD design, development and regulatory requirements