Senior Medical Director, Clinical Development- Nephrology

Job Description General

Summary:

The Senior Medical Director will define the clinical development strategy of povetacicept in primary membranous nephropathy, 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

As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

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

Supervisory experience required#LI-JM1#LI-Hybrid 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:$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…