Executive Medical Director, Clinical Development- Immunology

Job Description

General Summary:

The Executive Medical Director, Clinical Development for Vertex’s povetacicept immunology programs will provide high-level input on clinical development strategies and trial designs for early and late - stage programs . He/she will work closely with other relevant functional area leaders in Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, Business Development, and Marketing to develop i nnovative approaches to clinical development that optimize timelines and cost.

Key Duties and Responsibilities:

- Requires comprehensive understanding of the drug development process extending from Phase1 through 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.

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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:
$0 - $0

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 [email protected]