Associate Clinical Research Medical Director - Renal

Band

Level 5

 

Job Description Summary

• Accountable for all country clinical/medical aspects associated with Development and prioritized research programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative.
• 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 and Patient Engagement) 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

From Strategy to Functional Excellence

Provides Clinical Development and indication expertise specific to Country, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines:

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

• Develops clinical/medical trial plans taking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation, which includes:

  • Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans.

• Provides robust indication, compound, and protocol training

• Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.

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

• Accountable for adherence to safety standards, clinical data quality for the Country and provides general scientific/clinical/medical support for safety issues

Key performance indicators/Measures of success

• Meets Country specific clinical trial operations Key Performance Index (KPI) targets, particularly those related to trial feasibility and recruitment.

• Drives investigator site performance by providing high quality support to Investigators/Clinical trial site staff for Development and Biomedical Research studies, leading to a superior customer experience.

• Quality of scientific/clinical/medical input to Country and Global teams.

Ideal Background

Education                                      

• Advanced degrees required; M.D., M.D. equivalent, Ph.D., or Pharm.D.

• Nephrology Subspecialty or Renal clinical trial experience preferred

Experience/Professional Requirement:

• Ability to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.

• Ability to lead effectively by communicating well, motivating a cross- functional team, and handling and delegating responsibilities.

• Agility to move quickly across different therapeutic areas and indications.

• Demonstrated problem-solving skills and comfort with complexity.

• Ability to prepare and deliver high quality presentations.

• Ability to travel up to 30%

• Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice.

• Sound understanding of the overall clinical development process, and ICH/GCP principles.

Details of Technical Competency

Protocol Execution:

• Ability to assess the feasibility of implementing the protocol based on Country medical practice and sound understanding of the overall Clinical Development Plan.

Regulatory & Compliance:

• D