Medical Director – Oncology/Hematology , Home- Based (m/w/d)

• 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.

• 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 Safety Management 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.

• May assist sponsor in choosing committee members.
• May serve as a non-voting member to convene and organize proceedings.
• May develop operating guidelines in conjunction with committee members and submits these to sponsor for review.
• May determine data flow with sponsor to ensure reporting accuracy.
• Can ensure DSMB feedback is given to sites for IRBs.
• All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor.

• 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.

• Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
• 10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development.
• 3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience.
• 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.

• Current or prior license to practice medicine; board certification/eligibility ideal (Preference)
• Board Certified / Board Eligible: Oncology/ Hematology (Required)

Vacancies in Turkey