- Salary
- $320k – $480k
- Location
- 5000 - Vertex US - Fan Pier, United States of America
- Type
- Full-time
- Department
- IT
- Seniority
- Director
- Source
- Workday
Description
Job Description
Committed to advancing breakthrough treatments for patients with immune-mediated diseases, Vertex is building the clinical organization to match its scientific ambition in immunology. We are seeking a physician-scientist with a comprehensive understanding of molecular pathways as drivers of inflammatory and autoimmune diseases across a range of organs — and of the investigative treatment landscape targeting those pathways — to help shape Vertex's immunology portfolio beyond existing programs.
Povetacicept, our lead immunology asset, is a differentiated TACI-Fc fusion protein that dually inhibits BAFF and APRIL, now advancing into a broad portfolio of antibody-mediated autoimmune indications with compelling early signals. As Executive Medical Director, Clinical Development, you will serve as Vertex's primary physician voice on the povetacicept franchise in immunology while contributing your scientific perspective to how Vertex thinks about immunology more broadly about which programs to advance, which mechanisms to pursue, and how to position Vertex as a credible, durable force in a field that is moving fast.
This role operates at the intersection of Research, Regulatory, Medical Affairs, Global Patient Safety, Clinical Operations, Commercial, Pharmaceutical Development and Business Development.
Key Duties and Responsibilities:
- Requires comprehensive understanding of the drug development process extending from Phase 1 to Phase 4
- Is a recognized and respected authority in the immunology or rheumatology field
- Has experience overseeing clinical development programs and managing their design and implementation by providing project team leadership
- Participating in the planning and execution of global clinical development activities including setting up data monitoring committees, steering committees, and investigator meetings
- Representing the clinical development team at cross-functional meetings
- Develop study protocols
- Reviewing Investigator Brochures
- Reviewing and evaluating study subject exemptions
- Overseeing medical monitoring of clinical studies
- Assisting medical monitors in evaluating adverse events and safety profiles
- Participating in data reviews
- Participating in the development of briefing books and preparing the team for regulatory interactions
- Interfacing with international regulatory authorities to support development objectives
- Ensuring compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirements
- As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.
Knowledge and Skills:
- Experience interacting with global regulatory agencies including EMA, Health Canda, TGA, PMDA and CDE
- Possess a working knowledge of biostatistics, data management, clinical operations and clinical pharmacology
- Experience in filing and defending US INDs and/or NDAs and/or their international equivalents
- Ability to work in a fast-paced and ambiguous environment, and willing to provide hands-on assistance when needed to junior staff to help teams meet their goals
- Ability to function effectively in a team-based matrix environment
- Ability to work independently to resolve challenges and conflicts
- Excellent computer skills including familiarity using AI-based large language models to solve problems
- Excellent oral and written communication
- Excellent leadership skills
Education and Experience:
- 15 years pharmaceutical industry experience, including time designing and overseeing clinical trials and/or clinical development program(s), or the equivalent combination of education and experience
- 7 years of people management experience
- Immunology and/or rheumatology expertise
- Board certification/eligibility in immunology or rheumatology
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Pay Range:
$320,000 - $480,000Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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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 [email protected]