Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute’s Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
Summary of Position:
- Provide medical expertise and direction in global clinical drug development strategy and planning, and in the design, conduct, analysis and reporting of clinical trials
- Responsible for medical input to clinical development plans, protocols, risk management and safety handling plans
- Evaluates safety information, data analysis and interpretation, and report writing.
- You will serve as Medical Monitor/study support on a protocol/program basis
- You will ensure appropriate medical coverage to cover the medical monitoring safety requirements of ongoing trials during all hours of operation
- You will provide medical and scientific input to the preparation of clinical development plans, protocols, informed consent forms, case report forms, risk management plans, safety handling plans, clinical study reports, manuscripts, and other study documentations and publications
- You will provide medical and scientific input in the review of clinical data, patient medical safety data and laboratory values
- You will maintain ongoing assessment of all safety profiles and efficacy data for clinical trials managed by Sarah Cannon Development Innovations
- You will provide medical supervision and training to project teams and study sites
- You will provide medical monitor training to physician leadership team
- You will respond to Inclusion/Exclusion criteria questions from clinical sites, review violations and track trends, implementing appropriate preventative and/or corrective actions as necessary
- You will serve as medical expert in interactions with regulatory authorities and/or Institutional Review Boards/Independent Ethics Committees
- You will attend conferences, Dose Escalation Meetings, Safety Review Meetings, Data Safety Monitoring Board Meetings, Investigator Meetings, Kick-Off Meetings and Site Initiation Visits, as required
- Travel: 10-15%
You should have:
- Medical Doctorate (MD) Degree, Doctor of Osteopathic Medicine (DO) or Doctor of Pharmacy (PharmD) Degree
- At least 7 years of clinical research experience in a Contract Research Organization (CRO), biotech or pharmaceutical company
- At least 5 years of leadership experience
- At least 3 years of oncology experience
It would be preferred if you had:
- Medical Doctorate (MD) Degree
- At least 10 years of clinical research experience in a Contract Research Organization (CRO), biotech or pharmaceutical company
- At least 7 years of leadership experience
- At least 5 years of oncology experience in clinical trials phases I-III
Do you find this opportunity compelling, if so we encourage you to apply? We promptly review all applications. If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.
We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.