BASIC FUNCTIONS: The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Senior Medical Director also provides review, advice, and leadership for potentially or actually awarded clinical research programs. The Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. Major duties of the Senior Medical Director are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Functions as project team member
- Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting.
- Ensures medical activities run according to GCP and operate with highest efficiency
- Establishes and maintains a network of medical/scientific consultants, etc.
- Supervises and manages Medical Director activities
- Interacts with clients regarding drug development programs, study design and protocol.
- Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.
- Provides project team training on protocol and/or therapeutic areas
- Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
- Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
- Presents protocol and/or safety reporting information at investigator meetings.
- Develops project medical monitoring plans as requested
- Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
Safety Monitoring and SAE Reporting Activities:
- Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
- Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Pharmacovigilance Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.
- Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data
- In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind).
- Interact with appropriate FDA officials concerning safety and other study related issues, as requested.
- Provides medical review of eCRFs for clinical accuracy
- Provides medical review of data analysis plan
- Reviews safety fields at case freeze for reconciliation (if needed)
- Works with data group to reconcile SAE events as needed
- Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends.
- Reviews data tables, listings, and figures
- Reviews and/or writes portions of final clinical study report
DSMB/Adjudication Committee Activities:
- Assists sponsor in choosing committee members
- Serves as a non-voting member to convene and organize proceedings
- Develops operating guidelines in conjunction with committee members and submits these to sponsor for review
- Determines data flow with sponsor to ensure reporting accuracy
- Ensures DSMB feedback is given to sites for IRBs
Business Development Activities
- Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development.
- Supports business development activities with proposal development and sales presentations
- Participates in feasibility discussions relating to specific project proposals
- Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
- Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities
- Participate in a variety of team quality improvement efforts as necessary
- Perform other related duties as assigned or requested by the Chief Medical Officer.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
- Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment.
- Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
- Excellent oral and written communications skills as well as interpersonal skills are essential
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Ability to travel domestically and internationally as required.
- Very limited physical effort required to perform normal job duties.
MINIMUM RECRUITMENT STANDARDS:
- Licensed M.D.; board certification/eligibility ideal
- Minimum 3-5 years of biopharmaceutical industry experience in drug development and clinical research.