Companion Diagnostics Lead, Senior Director
Semma Therapeutics
Job Description
General Summary:
The Companion Diagnostics Senior Director is an independent leader with hands-on experience and strong understanding of the scientific, clinical development and regulatory aspects of developing and executing companion diagnostic (CDx).
You will build and lead the strategy and processes for development of CDx across programs at Vertex and will collaborate closely with both internal and external teams to develop program-specific CDx strategies and ensure timely and high-quality execution of CDx-related activities.
Key Duties and Responsibilities:
- Lead overall CDx strategy at Vertex and work with internal and external partners to develop and implement program-specific CDx strategies
- Provide critical technical and regulatory expertise
- Ensure alignment of CDx development milestones with clinical milestones
- Collaborate closely with Biomarker leads, clinical development, clinical operations, and regulatory representatives on the successful implementation of CDx assays and diagnostic data collection in clinical trials
- Work closely with commercial team to prepare for and support successful launch of CDx
- Develop and support forward-looking diagnostic development plans that enable broad access to high-quality diagnostic testing in the US, EU and other global markets
- Work closely with Biomarker leads on evaluation and selection of CDx partner
- Represent Vertex at external conference, meetings and discussions to present topics on CDx development and execution.
- Lead specific work streams as specialized technical expert and build the CDx capabilities within the team.
Education and Experience:
- MD or PhD
- 11 years in industry, 5+ years in CDx development and 5+ years of group management
- Broad knowledge and understanding of established and novel clinical and diagnostic assay technologies (e.g., NGS, PCR, IHC, ligand-binding assay)
- Experience with working on cross-functional teams in the biotech/ pharma industry, and how diagnostic development strategy can influence drug development and commercialization
- Ability to apply strategic and agile thinking to adapt to the evolving personalized healthcare environment
- Strong written and verbal communication skills and the ability to effectively communicate with cross-functional teams and present complex science clearly to various stakeholders within the organization
- Ability to work collaboratively across business areas and with diverse functional stakeholders in order to successfully meet project deliverables
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.