Associate Clinical Research Medical Director

Job Description Summary

Job Description Summary
• Accountable for all country clinical/medical aspects associated with Development and prioritized Re-search programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. May work across several countries.
• Gathers, informs, and acts on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation.
• Drives the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.
• Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings.
• In close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs, Patient Engagement, and Patient Access) actively contributes to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.

 

Job Description

Major accountabilities:

• Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.

• Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.

• Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.

• Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form(ICF) as needed and ensures appropriateness of patient suitable language.

• Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts(e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).

• Building disease area expertise, especially for new/rare indications.

• Provides robust indication, compound, and protocol training: To the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed.

• Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits.

• Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.

• May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.

• Follows-up with the Investigator for additional clinical/medical information or clarifications for AEs and SAEs and provides clinical/medical expertise for safety …