Associate Medical Director, Clinical Development-APOL1-Mediated Kidney Disease
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Job Location:
Boston, NH - USA
Monthly Salary:
$ 204000 - 306000
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Job Description
The Associate Medical Director will serve as the Medical Lead for Vertex clinical trials in our APOL1-Mediated Kidney Disease Program working with cross-functional multidisciplinary study teams on clinical trial strategy design and execution and serving as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials in Phases 1 through 3 and may also participate in selected projects in the Kidney clinical development program.
Key Duties and Responsibilities:
Participates in the development of Study Protocols Investigators 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:
$204000 - $306000Disclosure 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 EligibleFlex 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 Vertexs 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 persons 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
Required Experience:
Director
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.
