Executive Medical Director, Clinical Development- Immunology
Job Location:
Boston, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 Vertexs immunology portfolio beyond existing programs.
Povetaciceptour lead immunology assetisa 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. AsExecutive Medical Director Clinical Development you will serve as Vertexs primary physician voice on thepovetaciceptfranchisein immunologywhile contributing your scientific perspective to how Vertex thinks about immunology more broadlyaboutwhich 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 roleoperatesat the intersection ofResearchRegulatory Medical Affairs Global Patient Safety Clinical Operations Commercial PharmaceuticalDevelopmentand 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 clinicaldevelopmentprograms and managing theirdesign andimplementationby providingprojectteamleadership
- Participatingintheplanningand execution of global clinicaldevelopmentactivitiesincluding setting up data monitoring committeessteering committees andinvestigator meetings
- Representingthe clinical development team at cross-functional meetings
- Developstudyprotocols
- ReviewingInvestigatorBrochures
- Reviewingandevaluatingstudysubjectexemptions
- Overseeingmedicalmonitoringofclinicalstudies
- Assistingmedical monitors in evaluatingadverseeventsandsafetyprofiles
- Participatingindatareviews
- Participating in the development of briefing books and preparing the team for regulatory interactions
- Interfacingwithinternationalregulatoryauthoritiestosupportdevelopment objectives
- EnsuringcompliancewithVertexStandardOperatingProceduresInternationalConferenceon Harmonization Good Clinical Practice and other national and international regulatoryrequirements
- Asapeoplemanagerwithintheorganizationmayhavefinancialaccountabilitiesandhuman resource responsibilities for assigned staff.
Knowledge and Skills:
- Experienceinteracting with global regulatory agenciesincluding EMA Health Canda TGA PMDA and CDE
- Possessaworkingknowledgeofbiostatisticsdatamanagementclinicaloperationsand clinical pharmacology
- ExperienceinfilinganddefendingUSINDsand/orNDAsand/ortheirinternationalequivalents
- Abilitytoworkina fast-paced andambiguous environmentand willing to providehands-onassistancewhen needed to junior staffto help teams meet their goals
- Abilitytofunction effectively in ateam-basedmatrixenvironment
- Abilitytoworkindependentlytoresolvechallengesandconflicts
- Excellent computer skills includingfamiliarityusingAI-basedlarge language modelsto solveproblems
- Excellentoralandwrittencommunication
- Excellentleadershipskills
Education and Experience:
- 15yearspharmaceuticalindustryexperienceincludingtimedesigning and overseeingclinicaltrialsand/orclinical development program(s) or the equivalent combination of education and experience
- 7yearsofpeoplemanagementexperience
- Immunology and/orrheumatologyexpertise
- Boardcertification/eligibilityinimmunology or rheumatology
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Pay Range:
$320000 - $480000Disclosure 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 Vertexs 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 persons 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
Required Experience:
Exec
About Company
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.
