Medical Director (Oncology) in Romania

Everest has been a CRO since January 2004 with a strong foundation as a statistical, programming, and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Headquartered in Toronto, Canada, with subsidiary offices in New Jersey, USA; Shanghai, China; Taipei, Taiwan; Bulgaria, Romania, Poland, and Croatia in Europe. Everest continues to deepen capabilities and serve highly satisfied customers in data/analytics services and full-service execution with quality, effectiveness, and agility for worldwide clinical trials.

Growing steadily over 21 years, Everest is a preferred vendor for 100+ active clients, including major, mid-sized, and small pharmaceutical, biotech, and medical device companies. We value our clients and all growth to date is primarily from their repeat and referral business. We are known for our high-touch approach with client teams, high quality standards, customer-focus, “can-do” culture, advanced technology utilization, and continuous improvement. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Medical Director (Oncology) in Romania.

Key Accountabilities:

1. Work closely with business development and other internal stakeholders in critical appraisal of protocols, proposing study designs, and endpoint development.
2. As the primary medical monitor for assigned studies, be the first point of contact with sites; answer site questions about eligibility and enrollment; perform safety and patient management.
3. Be readily available to advise on assigned clinical trial related medical questions or issues that arise during the conduct of a clinical trial.
4. Work cross-functionally, and with sponsors, to define, plan, and provide medical monitoring for assigned clinical trials.
5. Provide medical expertise and input into the development of Medical Monitoring Plans and Safety Management Plans for the trial.
6. Review and provide medical input to the protocol and protocol training materials.
7. Conduct training for the project team concerning the disease/therapeutic area, study design, and procedures. If applicable, attend and participate in Investigator Meetings.
8. Provide consultation and support decisions relating to inclusion/exclusion criteria deviations for subject eligibility or other protocol-related questions.
9. Respond to medical queries from study Investigators, Ethics Committees, and trial Data Monitoring Committees.
10. Provide telephone and online (email) coverage for emergency medical guidance outside of normal business hours.
11. Ensure all protocol inquiries and answers are documented in the centralized tracker/CTMS.
12. Review listings, laboratory reports, and subject profiles as outlined in the Medical Monitoring Plan and Safety Management Plan.
13. Provide review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events (AEs) are identified and appropriate responses to such concerns are developed and executed.
14. Review safety data including serious adverse events (SAEs), laboratory data, medical history, and concomitant medications to assess patient risk or trends/signals of safety issues.
15. Provide consultation to the study team during review of out-of-range laboratory values for clinical/protocol significance.
16. Provide medical advice to the internal Pharmacovigilance/Drug Safety team on queries relating to the SAE case assessment and reporting for the trial.
17. Provide reviews of subject narratives, periodic and interim safety reports, and other study related documentation.
18. Assist with medical review of MedDRA-coded terms for AEs and medical histories, and WHODrug coded terms for concomitant medications/therapies.
19. Review the Statistical Analysis Plans; tables, figures, and listings; and the Clinical Study Reports (CSRs), as needed.
20. Ensure compliance with company Standard Operating Procedures and working practices for clinical trial safety medical monitoring.

Qualifications:

1. Doctor of Medicine (MD) from an accredited institution. A strong foundation in clinical medicine, combined with practical experience in medical research or clinical development, is essential. Additional certifications or training in specific therapeutic areas (e.g., hematology, oncology) may be an advantage, but the primary qualification must be an MD or equivalent medical degree.
2. At least 10-15 years of experience in clinical development, with a strong background in medical monitoring, clinical trial oversight, and pharmacovigilance.
3. Advanced certification, specialization, or other therapeutic area expertise in hematology, oncology, or another relevant medical field is highly preferred.
4. Proven experience in managing clinical trials in a Contract Research Organization or pharmaceutical company environment, with expertise in Phase I-IV studies.
5. In-depth knowledge of regulatory requirements (e.g., FDA, EMA) and ICH-GCP guidelines.
6. Strong leadership, organizational, and communication skills.
7. Ability to work collaboratively in cross-functional teams and interact effectively with both internal and external stakeholders.
8. Expertise in medical data review, safety oversight, and risk management in clinical trials.
9. High level of attention to detail and the ability to make informed decisions based on clinical data.
10. Ability to maintain confidentiality and handle sensitive medical and client data responsibly.
11. Experience working with global clinical trials and multi-regional study teams.
12. Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.ecrscorp.com

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.