Alliance Manager, CDx (ADX-295-20)
Alliance Manager, CDx (ADX-295-20)
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:
Lead companion diagnostic specific pharma alliance project portfolio in support of oncology biomarker assay development to deliver on key strategic collaboration goals.
RESPONSIBILITIES:
- Own pharma alliance in companion diagnostic development on NGS platforms for oncology indications, emphasis will be on activities required for assay development and clinical trial scoping and tracking, revenue models, enabling global regulatory submission and collaborative commercial launch communication with pharma partner, and establishing and extending pharma alliance partnership through creative application of existing processes and excellent communication.
- Supporting role for business development engaging with pharma partner(s) and facilitating contract development for opportunity.
- Work in collaboration with Program Management Office, Assay Development, Clinical Operations, Regulatory, and Commercial teams over multi-year projects to scope and deliver on contractual obligations and negotiate expansions and amendments in support of business development teams where needed.
- Ability to translate contractual obligations for finance, project management, and other business units (including forecasting CDx development for pipeline).
- Provides a supportive role for product development that creates visibility for pharma alliance partner(s); requires working knowledge of molecular biology, NGS applications for biomarker discovery, design control, good clinical and lab practice.
- Deploy excellent presentation and collaborative communication skills to manage Joint Steering Committee under Governance model. Develop and leverage a working knowledge of Legal, Finance, Assay Development, Manufacturing, Clinical, and Regulatory functions in order to enhance working alliance.
EXPERIENCE:
- >1 year experience working directly with a companion diagnostic
- 5+ years experience in pharmaceutical industry, medical device industry, or biotech experience required.
- Certificate of Achievement in Alliance Management, a plus.
- Knowledge of contracting life cycle, molecular biology, NGS, design and development, clinical trial management, 510K/PMA regulatory path, global regulatory requirements for medical device development, oncology indications, and oncology biomarkers, a plus, plus, plus. Otherwise, these will be areas you will be expected to learn and gain perspective on within the first six months of employment as they apply to the specific alliance and diagnostic platform you will be supporting
- Demonstrated communication skills, with provided examples: Awards, publications, coaching experience, etc.
EDUCATION:
- Masters or Ph.D. in Scientific or Engineering field