Executive Medical Director Clinical Development, Pain

Job DescriptionGeneral Summary:The Executive Medical Director, Clinical Development – Pain will provide high-level input on clinical development strategies on the project team for VX-548, in conjunction with other relevant functional area leaders in Medical Affairs, Regulatory, Commercial, Pharmaceutical Development, and Marketing. The successful candidate will initiate and lead innovative approaches to clinical development and commercialization.  In addition, there will be responsibility for delivering on late-stage clinical trials, building and managing a clinical development team, and ensuring that processes are in place and followed.Key Duties and Responsibilities:Provide clinical development recommendations to project teams, including optimizing study design and conduct for efficiency and effectiveness.Participate in planning for worldwide clinical development activitiesProvide guidance to multi-disciplinary development teamsReview study protocolsReview Investigator BrochuresReview and evaluate study subject exemptionsOversee medical monitoring of clinical studiesEvaluate adverse events and overall safety profileParticipate in data reviewsInterface with international regulatory authorities, as appropriate, in support of the development objectives for the compound or programEnsure compliance with Vertex Standard Operating Procedures, International Conference on Harmonization, Good Clinical Practice, and other national and international regulatory requirementsAs a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.Knowledge and Skills:Global clinical research experience and experience interacting with regulatory authorities is highly desiredPossesses a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development processPossesses a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processesExperience in filing and defending US INDs and/or NDAs and/or their international equivalentsEnterprise-wide thinking and ability to work in ambiguity, including being hands on in order to ensure the work that needs to be done by the team gets done; other duties as required or assignedAbility to work and lead collaboratively in a challenging fast-paced, team-based matrix environmentBroad and comprehensive understanding of the drug development processWell-respected authority in the external clinical development communityAbility to work independently to resolve challenges and conflictsExcellent oral and written communicationExcellent leadership skillsBoard certification/eligibility in a medical specialty desiredMay include up to 25% travel based on business needEducation and Experience:MD, DO or equivalent ex-US medical degreeBoard certification/eligibility in a specialty is highly desired15 years pharmaceutical industry experience, including time managing clinical trials and/or clinical development program(s), or the equivalent combination of education and experience7 years of management experience#LI-BS1Flex 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 select2.    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.Company InformationVertex 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.comSummaryLocation: Boston, MAType: Full time