Vertex Pharmaceuticals

Lead clinical trial medical oversight, develop study protocols, ensure safety and scientific integrity, and collaborate with cross-functional teams. | MD/DO or equivalent medical degree with 8+ years clinical research experience, expertise in clinical trial design, regulatory submissions, and safety monitoring. | Job Description General Summary: The Clinical Development Associate Medical Director generalized myasthenia gravis (gMG) will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting. In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may participate in other projects to support the clinical development program. Key Duties And Responsibilities • Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance • Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate • Provides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reports • Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies • Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results • Performs other duties as assigned related to other aspects of Clinical Development Knowledge And Skills • Strong oral and written communication skills • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate • Global clinical research experience and experience interacting with regulatory authorities is a plus • Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development • Board certification/eligibility, as well as clinical training in a relevant medical specialty is highly desired Education And Experience • MD, DO or equivalent ex-US medical degree • Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience Pay Range $198,300 - $297,400 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: • Hybrid: work remotely up to two days per week; or select • 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 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

Drive quality outcomes and operational excellence for GLP processes, collaborate on quality indicators, support regulatory reviews and audits, and contribute to inspection readiness and training. | Bachelor's degree in scientific field, strong GLP experience, pharmaceutical or CRO background preferred, ability to work independently, and excellent communication skills. | Job Description: The GLP Operational Quality Manager/Sr. Manager supports quality oversight for the GLP-related processes and activities. The incumbent will support business partners and GLP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas. The GLP Operational Quality Manager/Sr. Manager will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Manager/Sr. Manager, GLP Operational Quality will also collaborate with the Quality Analytics team to review and support the development of meaningful quality indicators to permit ongoing evaluation of process and quality system health and identification of risks. Job Description We are seeking a dedicated and experienced Good Laboratory Practice Quality Manager/Sr. Manager to support our company's quality oversight for GLP-related processes and activities. As a GLP Quality Manager, you will collaborate with various stakeholders and the GLP Operational Quality team to drive quality outcomes and operational excellence. Your primary responsibility will be to ensure compliance, excellence in quality, and readiness for future needs. Key Responsibilities: • * Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence. • Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality. • Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, as well as risk identification. • Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs. • Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDA's. • Provide input in the development of audit scope and focus for vendor audits. • Contribute to pro-active inspection readiness activities by conducting quality assessments of GLP studies either on-site or remotely. • Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities. • Participate in creating and presenting content for annual GLP refresher training. Perform other duties as assigned. Requirements: • * Bachelor's degree or equivalent in a related scientific field. • Strong experience in GLP (Good Laboratory Practices) and reviewing data and documents supporting GLP studies and submissions. • Experience in Pharmaceuticals or Contract Research Organization (CRO) • RQAP-GLP certification is preferred, but not mandatory. • Ability to work independently and meet timelines in a fast-paced environment. Excellent communication and collaboration skills. Travel Requirements: This role may require up to 20% travel. Travel primarily includes visiting CROs for conducting Quality Reviews focused on data reviews. Some travel to Boston may be required for training or stakeholder engagement. Pay Range: $75-$85/hr Requisition Disclaimer: This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners (collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com. If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email. No C2C or Third-Party Vendors