Medical Director, Hematologic Oncology
NateraSalary not specified
Internship
Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries
Requirements
- Medical expertise in hematology or related field (implied by role and responsibilities)
- Ability to function as a team member in a matrix reporting structure
- Availability for 24/7 on-call coverage for protocol queries, site support, and safety issues
- Knowledge of GCP (Good Clinical Practice) standards
- Experience in clinical research, including protocols, preclinical/clinical data review, and regulatory submissions
- Ability to establish and maintain networks of medical/scientific consultants
- Supervisory skills for managing Medical Director activities
Responsibilities
- 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 evaluations
- Ensure medical activities comply with GCP and operate efficiently
- Interact with clients on drug development programs, study design, and protocol development, including input on inclusion/exclusion criteria, endpoints, statistical/data management sections
- Review final protocols for clinical, safety, and efficacy variables
- Provide project team training on protocols and therapeutic areas
- Assist in investigator site selection, networking, and final selection
- Participate in subject recruitment and retention, including calls to key opinion leaders/investigators and presentations at investigator meetings
- Develop project medical monitoring plans
- Assist teams and sites with protocol-related, study-related, or medical questions
- Provide recommendations for urgent/non-urgent safety events per protocol
- Serve as first-line contact for investigators and monitors on medical/safety issues, protocol compliance, and patient eligibility
- Verify medical accuracy of patient safety data and conduct ongoing safety profile assessments
- Review SAE reporting, write/review SAE narratives, track SAEs, follow up on safety queries, and interact with sponsors/sites on safety issues
- Review IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports
- Supervise and manage Medical Director activities
Skills
Hematology
Clinical Trials
GCP
Medical Monitoring
Protocol Review
Adverse Event Evaluation
Regulatory Submissions
Drug Development
eCRFs
Clinical Study Reports
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