Medical Director - Los Angeles, United States - Meet

Description

Title:

Senior Medical Director, Clinical DevelopmentDescription: 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.


Responsibilities:

Protocol Development:
Lead the creation of study protocols for investigational products, ensuring compliance with regulations and operational feasibility

Clinical Study Oversight:
Manage the execution of clinical studies, including data management, safety monitoring, and study closure

Committee Support:
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

Clinical Expertise:
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

Publication Strategy:
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. Stay updated on relevant literature for program development.


Qualifications:
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 REQUIREDDesired experience in health authority interactions and regulatory submissions.
Strategic thinker with excellent communication and decision-making abilities.
Flexible and able to manage multiple projects independently.


Location:
Remote#J-18808-Ljbffr