Vertex

Biotechnology

ClinicalDevelopmentAssociateMedicalDirectorPain

$204–306k Boston, Massachusetts, United States FULL TIME Remote Friendly
The Brief

“Clinical Development Associate Medical Director- Pain at Vertex. Skills: Clinical development, Medical monitoring, Regulatory submissions. Serve as Medical Lead for clinical trials. Work with cross-functional teams on trial strategy”

Industry & Context.

Biotechnology

What They're Looking For.

Must Have

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

Nice to Have

Global clinical research experience, Experience interacting with regulatory authorities, Board certification/eligibility in a relevant medical specialty, Clinical training in a relevant medical specialty

What You'll Do.

Serve as Medical Lead for clinical trials

Work with cross-functional teams on trial strategy

Design clinical trials

Execute clinical trials

Report on clinical trials

Monitor safety of enrolled subjects

Ensure scientific integrity of studies

Participate in other projects

Develop Study Protocols

Develop Investigator's Brochures

Develop Clinical Development Plans

Serve on cross-functional Study Execution Teams

high-quality study execution

Prepare regulatory documents

Support regulatory submissions

Prepare clinical section of INDs

Prepare IND safety reports

Prepare annual reports

Respond to regulatory authorities

Respond to Ethics Committees/IRBs

Provide scientific input to study documents

Provide clinical input to study documents

Provide input to analysis plans

Provide input to informed consent forms

Provide input to clinical research forms

Provide input to statistical analysis plans

Provide input to clinical pharmacology analysis plans

Provide input to clinical study reports

Act as liaison between Clinical Development and internal

Represent Vertex to outside medical personnel

Develop clinical protocols

Conduct study conduct

Report study results externally

Perform other duties as assigned

How You'll Work.

Team & Collaboration

Cross-functional teams; Study Execution Teams; Internal groups at Vertex

Communication Scope

Oral communication; Written communication

Free ATS check

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