Clinical Development/Science Lead (Director) (ADX-20-21)

COMPANY SUMMARY:

In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com. 
POSITION SUMMARY:

The Clinical Science Lead/Director is a critical member of the Oncology Diagnostics. They will be responsible for clinical strategy at the project level and provide clinical expertise in diagnostic product development, clinical trial design and regulatory submissions. The successful candidate must possess a thorough understanding of the oncology diagnostic and therapeutic spectrum as they relate to clinical biomarker development, regulated product development, the oncology therapeutic landscape, and the regulatory guidelines for diagnostic submissions. They will have the ability to identify and define critical test attributes that affect conduct of clinical research and potential impact on overall product design. A collaborative approach is essential for this leader as they will interface and work in partnership with multiple cross-functional teams across different locations in support of programs pivotal to ArcherDX. 
RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Work with the Oncology Diagnostic teams to design, implement, interpret, report and publish clinical studies for regulatory applications.
• Assist Product Development with clinical implications of assay design, design of performance verification, analytical study design and assay and instrument readiness for clinical trials
• Provide medical/scientific input into and assists with the preparation of regulatory submissions. Prepare and provide responses to clinical questions or requests from regulatory agencies
• Provide clinical expertise and leadership to Clinical Operations, Data Management, Biostatistics, Medical Affairs, Regulatory Affairs, Quality/Design Assurance, Product Development and Product Management groups
• Identifies and defines critical clinical test attributes that affect the conduct of clinical research and potential impact on overall product design and lifecycle
•  Explore and define potential clinical utility for company products and clinical bridging strategies for Clinical Trial Assays
• Chairs Investigator Initiated Trial Committee overseeing external academic partnership projects ensuring clinical utility and product development needs are addressed
• Provide medical opinions and analysis of product safety.
• Assist Medical Affairs in guidance to the Product Management teams to ensure marketing and promotional materials are both scientifically accurate and medically sound
• Review publications by ArcherDX and external collaborators for scientific and medical content
• Serve as a clinical sciences expert at ArcherDX, keeping the company abreast of advances in relevant precision medicine and health systems, as they relate to Oncology Diagnostics
• Over time, develop and retain highly skilled and effective Clinical Science team to support ongoing programs and future development opportunities
• Strategically partner across ArcherDX on the design and execution of robust clinical strategy
• Authors and reviews standard operating procedures and adheres to ArcherDX quality standards
• Effectively communicate and discuss complex diagnostic clinical science and IVD development issues with project teams, upper leadership and external partners
• Safeguarding the privacy and security of protected health information and European Union personal data
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology
• Provide insight to pipeline determination in clinical feasibility, and translate findings from research and nonclinical studies into clinical development opportunities
• Contribute relevant clinical sections to documents such as the Investigator Brochures, Significant Risk Determination or Investigational Device Exemption
• Responsible for analyzing clinical data, drafting reports, abstracts, posters, CSRs and presentations on the various findings of the clinical research

EDUCATION:

• PhD in biological sciences, MD or MD/PhD with specialization in oncology and/or molecular pathology

EXPERIENCE:

•  Minimum of 5 years (preferably 10+) of Clinical Science and Clinical Development experience in the oncology diagnostics and therapeutics
• Broad understanding of Oncology diagnostics and treatment landscape
• Up to date knowledge of novel NGS technologies and their application in Oncology diagnostics
• Experience in diagnostic, drug and CDx co-development trials
•  Deep understanding of the CDx development process and regulatory landscape
•  Working knowledge of GCP, GLP and federal and local regulations
• Proven clinical development strategist with experience designing, implementing and conducting diagnostic clinical trials
• Extensive strategic leadership and communication skills with strong initiative, ethics, and judgment, and demonstrated ability to positively represent the goals of the organization
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
• Possess an understanding of applicable US and EU drug development regulations and GCP regulations
• Proven ability to manage timelines and adhere to budgetary requirements
• Experience in interfacing with and presenting to executive leadership and external partners
• Experience building effective teams and managing conflict
•  Effective at attracting, developing and retaining talented team members.
• Willing to lead, act as a player-coach and roll up his/her sleeves and do what is necessary to meet project and corporate goals
• Excellent verbal and written communication and presentation skills Excellent project management skills

KEY ATTRIBUTES:

• Drive and determination
• Ability to work in a fast paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects
• Ability to build strong relationships within all parts of the company. Strong communication and presentation skills
• Driven to perform
• Self-directed: needs little explicit direction
• Able to organize, prioritize, and delegate tasks to efficiently move projects forward.