Clinical Development Associate Medical Director- gMG

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 240,000 - 360,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Medical, dental and vision benefits

Paid time off

Educational assistance programs

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex Pharmaceuticals Incorporated in Boston is seeking a Clinical Development Associate Medical Director to serve as the Medical Lead for clinical trials, guiding strategy, design, execution and reporting across programs. You will oversee trial safety and scientific integrity as the internal primary Medical Monitor.

The role may involve broader contributions to the clinical development program. You will interact with Regulatory Affairs and Clinical Development Execution, provide input for

Qualifications

• MD, DO or equivalent medical degree required.
• 8+ years of basic or clinical research experience in academia or industry suggested.

Responsibilities

• Develop Study Protocols and related regulatory documents with minimal guidance.
• Participate in cross-functional Study Execution Teams to ensure efficient trial execution.
• Prepare regulatory submissions including IND/CTA sections and safety reports.
• Provide scientific input to study documents and analysis plans.
• Act as liaison between Clinical Development and other Vertex groups.
• Represent Vertex to external medical personnel in protocol development and reporting.
• Perform other duties related to Clinical Development.

Skills

Communication skills

Team collaboration

GCP knowledge

Clinical study design

Regulatory submissions experience

Scientific writing

Education

MD, DO or equivalent ex-US medical degree

Job description

Job Description

General Summary:

The Clinical Development Associate Medical Director 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:

$240,000 - $360,000

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.

• annual bonus and annual equity awards
• overtime pay, in accordance with federal and state requirements
• 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
• medical, dental and vision benefits
• 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)

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.

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.