Associate Clinical Research Medical Director , Immunology
Remote Position (USA), United States
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 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
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 time- lines:
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 external Experts (e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Develops clinical/medical trial plans taking the broader ecosystem into account for assigned pro- grams/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.
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.
Externally as needed in the Country at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
Leverages innovation …
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Remote position
Benefits/Perks401k eligibility Discretionary awards Diverse teams Flexible schedule Paid Time Off Professional development opportunities Remote work Restricted Stock Units
Tasks- Collaborate with stakeholders
- Compliance
- Ensure data quality
- Lead clinical development
- Manage clinical trials
- Provide training
- Training
Advocacy Clinical Data Clinical Development Clinical operations Clinical Practice Clinical Research Clinical Trial Management Clinical trial operations Clinical trials Collaboration Compliance Customer Experience Data analysis Data Quality Data Quality Assurance Design Drug Development Education Ethics Execution GCP ICH Implementation Insights Leadership Management Marketing Medical Medical Affairs Medical Leadership Medical Strategy Monitoring Operations Patient Access Patient advocacy Patient Engagement People Management Pharmacovigilance Problem-solving Protocol Development Recruitment Recruitment Strategy Regulatory Affairs Regulatory Compliance Safety Standards Scientific Expertise Stakeholder Collaboration Strategy Study Design Training Training and Development
Experience5 years
Education TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9