Early Development Associate Medical Director

MFS Investments; Boston (MA); Hybrid; USD 204,000 - 306,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

Paid Time Off

Student Loan Repayment Support

Commuting Subsidy

401(k) Match

Educational Assistance

Job summary

Vertex is seeking an Early Development Associate Medical Director to lead Phase 1 trials as the Medical Lead and internal Medical Monitor, overseeing safety and scientific integrity while collaborating across Research, Biomarkers, Regulatory Affairs and Global Clinical Operations.

Role involves cross-functional study execution, regulatory documentation, and liaison duties; requires MD/DO and 8+ years of research experience in academia or industry, with a hybrid work option.

Qualifications

• MD, DO or equivalent ex-US medical degree.
• Typically requires 8 years of basic or clinical research experience.

Responsibilities

• Participates in development of Study Protocols, Investigator's Brochures, Early Development Plans and other key documents.
• Serves on cross-functional Study Execution Teams (SET) for assigned trials.
• Prepares regulatory documents for regulatory submissions, including clinical sections of INDs/CTAs, safety reports and annual reports; responses to authorities.
• Provides scientific and clinical input to study-related documents and analysis plans.
• Acts as liaison between Early Development and other Vertex groups.
• Represents Vertex to outside medical personnel in protocol development, study conduct, and external reporting of results.
• Performs other duties related to Early Development.

Skills

Communication

Cross-functional teamwork

Regulatory experience

Biostatistics

Pharmacology

Pharmacokinetics

GCP knowledge

Study design

Manuscript preparation

Oral presentations

Education

MD/DO or equivalent ex-US medical degree

Job description

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.

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 [e-mail]