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    (Sr) Medical Director - (Cro Services / Oncology)

    Caidya
    10+ years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Medical Director or Senior Medical Director
    Location: United States or Canada - Remote

    Job Overview:
    The Medical Director is responsible for overseeing medical and safety aspects of clinical trials, ensuring participant safety and data integrity in accordance with clinical protocols, SOPs, GCP, and regulatory requirements. This role also supports corporate business opportunities.

    Key Responsibilities:

    Medical Monitoring:

    • Provide medical oversight of projects to ensure compliance with GCP, regulatory requirements, and Sponsor directives.
    • Consult with Sponsors and project teams on protocol development and project activities.
    • Remain accessible to sites and project teams for medical inquiries related to safety, protocol questions, eligibility criteria, and dosing.
    • Develop and update the Medical Monitoring Plan (MMP) and circulate for approval.
    • Review project-specific plans, including the Safety Management Plan (SMP), and relevant documents (e.g., study protocols, informed consent forms).
    • Assess and interpret project results, reviewing medical literature for document preparation.
    • Address protocol compliance issues, including deviations and corrective actions.
    • Train CRAs and team members on medical and safety topics related to projects.
    • Attend internal and external project meetings, and review laboratory results as needed.
    • Conduct medical review and assessment of SAEs, adverse events, and periodic safety reports.
    • Analyze study data for inconsistencies and manage queries.
    • Respond to requests from regulatory authorities and IRBs, as needed, and escalate urgent safety issues.
    • Collaborate with various departments (e.g., Safety/Pharmacovigilance, Project Management) to ensure effective medical operations.

    Business Development Support:

    • Assist in business development by preparing protocol considerations for new proposals and responding to Requests for Information.
    • Participate in bid defense meetings to provide medical and scientific insights for potential projects.
    • Work with Feasibility teams to identify suitable sites and review feasibility questionnaires.

    Supervisory Responsibilities:

    • No direct reports, but mentor and assist in training team members.

    Job Requirements:

    Education:

    • MD (or equivalent) required; postgraduate training and eligibility for licensure preferred.

    Experience:

    • Minimum of 3 years of direct oncology practice experience and at least 5 years of research experience post-training, preferably in a CRO environment.
    • Experience in medical monitoring activities and reviewing safety information is essential.
    • Prior experience delivering therapeutic area training and representing the company in client meetings is preferred.

    Skills/Competencies:

    • Deep understanding of therapies and drug-induced diseases.
    • Comprehensive knowledge of medical device, vaccine, and drug development processes.
    • High-level understanding of pharmacovigilance and extensive knowledge of GCP and regulatory guidance.
    • Strong communication skills, including presentations, and ability to maintain a positive, winning attitude.
    • Decision-making skills and the ability to establish and articulate clear team goals.
    • Ability to prioritize tasks with a sense of urgency and mentor others.

    Capabilities:

    • Proficient in Microsoft Office applications and comfortable using computers.
    • Willingness to travel occasionally for business needs.

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