Medical Director Health Services - California, United States - Meet

Description

Title:
Senior Medical Director, Clinical Development


Description:

The Senior Medical Director, Clinical Development is a vital contributor to clinical development programs, overseeing study-specific activities, collaborating with cross-functional teams, and supporting regulatory activities.

Responsibilities include protocol design, data analysis, committee support, document authorship, stakeholder interaction, publication strategy, regulatory engagement, and literature reviews.


Clinical Study Oversight:
Manage the execution of clinical studies, including data management, safety monitoring, and study closure.
# Facilitate Data Monitoring Committees and other data review committees, preparing updates and synthesizing data reports.
# Document Preparation:
Author clinical study reports, investigator brochures, and other regulatory documents. Develop training materials for study teams.
# Stakeholder Engagement:
Interact with internal and external stakeholders, providing guidance and support for program-level development strategy and clinical trial objectives.
# Serve as a clinical expert for assigned programs, collaborating with Medical Affairs on Investigator-Sponsored Trials (ISTs) and publication strategy.
# Regulatory Collaboration:
Work with Regulatory Affairs on submissions, investigator brochures, and communication with regulatory agencies.
# Contribute to publication strategy execution, including abstracts, posters, and presentations at scientific meetings and conferences.
# Literature Review:
Conduct literature reviews to inform development strategy and scientific hypotheses. MD or MD/PhD with 3+ years (5+ without oncology training) in pharmaceutical or biotech as (Associate) Medical Director.
Expertise in oncology or malignant hematology, with strong analytical skills REQUIRED
Desired experience in health authority interactions and regulatory submissions.
Flexible and able to manage multiple projects independently.


Location:
Remote

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