Role Summary
The Associate Clinical Research Medical Director CRM serves as the Country Clinical Development representative, providing clinical strategic and tactical leadership across development programs and prioritized trials. They gather and apply clinical, medical, and scientific insights to trial concept sheets, protocols, informed consent forms, and other clinical documents to optimize trial implementation. They identify and engage investigators with strong recruitment potential, address recruitment hurdles, and ensure adherence to safety standards and data quality. They collaborate with country functions such as Clinical Trial Operations, Medical Affairs, and Patient Engagement to enable fast start-up, timely recruitment, and mitigation of potential delays. Location: Remote.
Responsibilities
- Actively contribute to scientific/clinical/medical start-up activities to ensure fast trial site start-up.
- Develop clinical/medical trial plans considering the broader ecosystem to ensure successful trial implementation, including pro-actively identifying early recruitment or data quality challenges and developing mitigation plans.
- Provide robust indication, compound, and protocol training.
- Leverage innovation in clinical trial planning and decide on clinical/medical recruitment strategy and implementation based on physician interviews, analysis of competitive trials, and patient engagement.
- Review and resolve country trial-related scientific/clinical/medical issues; if necessary, initiate discussion with the Global Clinical Development team.
- Accountable for adherence to safety standards and clinical data quality for the country and provide general scientific/clinical/medical support for safety issues.
- Collaborate with the Clinical Trial Operations team to drive fast site start-up, timely recruitment, and development and implementation of mitigation plans.
- Meet country-specific clinical trial operations KPI targets related to feasibility and recruitment.
- Drive 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.
- Provide high-quality scientific/clinical/medical input to country and Global teams.
Qualifications
- Required: 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.
- Required: Ability to lead effectively by communicating well, motivating a cross-functional team, and handling and delegating responsibilities.
- Required: Agility to move quickly across different therapeutic areas and indications.
- Required: Demonstrated problem-solving skills and comfort with complexity.
- Required: Ability to prepare and deliver high quality presentations.
- Required: Ability to travel up to 30%.
- Preferred: Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice.
- Preferred: Sound understanding of the overall clinical development process, and ICH/GCP principles.
Skills
- Strategic and tactical clinical leadership and cross-functional collaboration.
- Strong communication and presentation skills; ability to influence and motivate across teams.
- Problem-solving, analytical thinking, and the ability to navigate complex scientific and operational issues.
- Ability to move quickly across therapeutic areas and indications; adaptability and learning agility.
- Project/clinical trial planning and execution; stakeholder management.
- Regulatory and compliance awareness relevant to clinical trials (ICH/GCP).
- Safety monitoring and medical expertise to facilitate safe use of products in trials.
Education
- Required: Advanced degrees required; M.D., M.D. equivalent, Ph.D., or Pharm.D.
- Preferred: Cardiology Subspecialty or Cardiovascular clinical trial experience.
Additional Requirements