Senior Medical Director, Oncology/Hematology at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Medical expertise in oncology/hematology or related therapeutic areas
Experience functioning as a Medical Monitor or providing medical oversight for clinical trials
Ability to serve as primary contact for sponsor medical teams and frontline medical resource, available 24/7 for protocol queries, site support, and alert labs
Knowledge of GCP (Good Clinical Practice) and regulatory requirements (e.g., FDA interactions, IND/SUSAR reports)
Experience in drug development programs, including review of preclinical/clinical data, protocols, informed consent, Investigator Drug Brochures, eCRFs, analysis plans, and clinical study reports
Ability to establish and maintain networks of medical/scientific consultants, key opinion leaders, and investigators
Supervisory experience managing Medical Director activities

Responsibilities

Function as project team member in a matrix reporting structure
Provide medical and scientific input to clinical research programs, including review of new business proposals, preclinical/clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plans, clinical study reports, regulatory submissions, and adverse event evaluation/reporting
Ensure medical activities comply with GCP and operate efficiently
Supervise and manage Medical Director activities
Interact with clients on drug development, study design, and protocol development, including input on inclusion/exclusion criteria, endpoints, statistical/data management sections, and final protocol review
Provide project team training on protocols and therapeutic areas
Assist with investigator site selection, networking, and final selection
Participate in subject recruitment/retention, including calls to KOLs/investigators/site staff and presentations at investigator meetings
Develop project medical monitoring plans
Provide on-call coverage for protocol queries, site support, medical/safety issues, and patient eligibility resolution
Verify medical accuracy of patient safety data, conduct ongoing safety profile assessments, review SAE reporting/narratives, track SAEs, follow up on safety queries, interact with sponsors/sites, review IND/SUSAR reports, Investigator Brochure updates, and annual IND reports
Follow procedures for breaking the blind in consultation with sponsors
Interact with FDA officials on safety/study issues as requested
Provide medical review of eCRFs, data analysis plans, safety fields at case freeze, SAE reconciliation, medical coding of AEs/labs/concomitant meds, data tables/listings/figures, and portions of final reports

Skills

Key technologies and capabilities for this role

Medical MonitoringClinical TrialsGCPProtocol DevelopmentAdverse Event ReportingRegulatory SubmissionseCRFInformed ConsentInvestigator BrochuresOncologyHematologyDrug DevelopmentStudy Design

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the key responsibilities or skills required for the Senior Medical Director role?

Key responsibilities include providing medical oversight as Medical Monitor for clinical trials, reviewing protocols and safety data, interacting with sponsors and investigators, ensuring GCP compliance, and handling SAE reporting and on-call coverage.

What is the team structure like for this position?

The role is a team member participant functioning in a matrix report to project teams, similar to other project team members, and involves supervising and managing Medical Director activities.

What makes a strong candidate for this Senior Medical Director position?

Strong candidates will have expertise in oncology/hematology clinical trials, experience as a Medical Monitor providing 24/7 support, skills in protocol review, safety monitoring, GCP compliance, and networking with investigators and sponsors.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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