Executive Medical Director, Clinical Development- Immunology

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 pharmaco logy

Experience   in   filing   and   defending   US   INDs   and/or   NDAs   and/or   their   international   equivalents

Ability   to   work   in   a fast-paced and   ambigu ous 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 includ ing   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

Immunolo gy and/ or   rheumatology   expertise

Board   certification /eligibility   in   immunology or rheumatology

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Pay Range:

$320,000 - $480,000

Disclosure 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 Eligible

Flex 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 ApplicationAssistance@vrtx.com