Early Development Associate Medical Director

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,…