Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
Lead companion diagnostic specific pharma alliance project portfolio in support of oncology biomarker assay development to deliver on key strategic collaboration goals.
- 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.
- 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.
- Masters or Ph.D. in Scientific or Engineering field
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
Expected Pay Rate in Colorado from: $80,000
Compensation for the role will depend on a number of factors, including a candidate’s geographic location, qualifications, skills, competencies and experience and may fall outside of the range shown.
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.