Job Title: Medical Director
Job Description: Element Staffing is recruiting for Medical Director for a biotechnology company headquartered in Houston, Tx. The Medical Director will assist in the preparation of protocol writing for and operational execution of clinical studies and will support medical affairs activities involving interaction with investigators and advisory boards. They will assess external clinical research proposals involving company products and manuscripts that are being prepared for publication.
- Lead for development of study designs, protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
- Responsible for preparing clinical portions of Investigational New Drug submissions.
- Establish and maintain relationships with alliance partners, external companies (such as CROs), investigators and opinion leaders to optimize performance on clinical trial activities
- Develop and maintain key opinion leader relationships and assist with advisory meetings
- Key player in organizing and participating in Investigator Meetings, Steering Committees, Data Monitoring Committee Meetings, adjudication committees and preparation of related material
- Medical Lead, responsible for providing medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team
- Assist with medical monitor duties with medical monitor from CRO
- This position requires a minimum of an advanced degree in medicine (M.D. or equivalent).
- Knowledge of basic and clinical cancer or hematology research and its application to drug development is required.
- A board-certified hematologist or oncologist or an individual with substantial previous experience in conducting oncology clinical studies is highly desired.
- A minimum of 3 years’ experience in a clinical research position in an academically-based research institute or within the pharmaceutical industry is highly preferred.
- Good oral, written, and presentation skills (including report development) are essential.
- Successful work experience in a matrix team environment is preferred.
- A strong commitment to hematology/oncology clinical research and the ability to work well within a team setting.
Assignment Type: Direct Hire
For immediate consideration, please send your resume to [email protected]