Clinical Development Senior Medical Director- gMG

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 281,000 - 421,000; Full time

Benefits offered by this job

Hybrid-Eligible

On-Site eligible

Annual bonus

Equity awards

Job summary

Vertex Pharmaceuticals Incorporated seeks a Senior Medical Director to define the clinical development strategy for an asset and to lead cross-functional teams through trial design and execution.

The role includes oversight of study protocols, regulatory submissions, and medical monitoring, with liaison to regulatory authorities and involvement in strategic planning. Hybrid-Eligible or On-Site options are available under Vertex's flex program.

Qualifications

• MD/DO or equivalent ex-US medical degree.
• Board certification or eligibility in a specialty.
• Typically requires extensive pharma/biotech experience with clinical trials.

Responsibilities

• Defines a clinical development strategy and prepares corresponding plans.
• Leads study protocol development and statistical analysis planning with minimal guidance.
• Oversees project teams and ensures execution of the approved strategy.
• Prepares regulatory documents for submissions and communicates with authorities.
• Oversees medical monitoring and interfaces with regulators as needed.
• Contributes to business development and strategic planning activities.
• Provides medical leadership for cross-functional teams and study conduct.

Skills

Global clinical research

Regulatory interactions

Cross-functional teamwork

Independent problem solving

Excellent communication

Education

MD/DO or equivalent ex-US degree

Board certification/eligibility

Job description

Job Description

General Summary

The Senior Medical Director will define the clinical development strategy of an asset, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.

Key Duties and Responsibilities

• Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas
• Participates in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
• Leads the Project Team, and works with cross-functional team members to define a project strategy and ensure execution against approved strategy
• Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
• Interfaces with regulatory authorities as appropriate
• Monitors and/or oversees medical monitoring of clinical studies
• Participates in business development and strategic planning activities
• Acts as liaison between clinical development and other internal groups at Vertex for assigned studies
• Provides medical and development leadership for cross-functional teams
• Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
• Represents Vertex to outside medical personal in the development of clinical protocols and study conduct

Knowledge and Skills

• Global clinical research experience, and experience interacting with regulatory authorities is highly desired
• Ability to work collaboratively in a fast-paced, team-based matrix environment
• Ability to work independently to resolve challenges
• Enterprise-wide thinking and ability to work in ambiguity
• Ability to ensure the completeness of team work
• Excellent oral and written communication skills
• Board certification/eligibility in a specialty is highly desired

Education and Experience

• MD, DO or equivalent ex-US medical degree
• Board certification/eligibility in a specialty is highly desired
• Typically requires 12 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs, or the equivalent combination of education and experience

Pay Range

$280,600 - $420,800

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

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]