Early Development Associate Medical Director

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 204,000 - 306,000; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

Generous PTO

Student loan repayment

Commuting subsidy

Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks an Early Development Associate Medical Director to lead Phase 1 trial medical strategy, monitor safety, and ensure scientific integrity.

You will collaborate with cross-functional teams, prepare regulatory documents, and represent Vertex to external clinicians and regulators.

This hybrid role offers a comprehensive rewards package, including annual bonus, equity awards, generous PTO, student loan support, and a mobility/subsidy program.

Qualifications

• MD/DO or equivalent medical degree required.
• Typically requires 8 years of basic or clinical research experience in academic or industry settings.
• Board certification/eligibility highly desirable.

Responsibilities

• Lead development of study protocols, Investigator's Brochures, and early development plans.
• Participate in cross-functional Study Execution Teams for trial quality and timely execution.
• Prepare regulatory documents including IND/CTA sections and safety reports.
• Liaise with internal Vertex groups and represent Vertex to external medical personnel.

Skills

Communication

Teamwork

Global clinical research

Regulatory interactions

Clinical monitoring

Education

MD/DO or equivalent ex-US medical degree

Job description

## Early Development Associate Medical DirectorApply: Boston, MA: Full time: Posted Today: REQ-30384**Job Description****General Summary:**The Early Development Associate Medical Director will serve as the Medical Lead for Phase 1 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, Early 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 Early Development and other internal groups at Vertex (e.g., Research, Biomarkers, Regulatory Affairs, Global Clinical Operations) 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 Early 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 At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.**Pay Range:**$204,000 - $306,000**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.#LI-Hybrid