The Medical Director (MD) will report to the VP of Clinical Development in the Clinical group and help drive the development of one or more molecules from pre-phase 1 through global registration.
Duties & Responsibilities:
- Drive effective clinical development and quality execution of the program.
- Project Clinician/ Medical Monitoring responsibilities with medical oversight from the VP Clinical Development or designee MD.
- Contribute to the compound’s development strategy and assisting with protocol design. As such, contributing to the writing of clinical development plan, clinical studies, etc.
- Provide scientific and clinical expertise in the development and writing of clinical protocols and clinical development plans that strive to achieve the target product profile. This may include identifying and reaching out to KOLs, as well as organizing and leading meetings with external experts to obtain guidance on study designs.
- Serve as a contributing author to documents supporting regulatory submissions, as well as abstracts, posters, oral presentations and publications.
- Contribute to the clinical and scientific background sections of various documents, including Protocols (as described above), Investigator’s Brochures, INDs, CTAs, Study Reports, Clinical Summaries, Clinical Overviews, and other documents.
- Accountable for the day-to-day clinical deliverables for the program, with a focus on clinical studies that are ongoing and being developed.
- The Medical Director will review SAE reports, AE and SAE listings, AE coding, concomitant medication coding, medical history coding, tables and listings of safety and efficacy data, and other output from clinical studies.
- Participate in analyzing and interpreting data from clinical studies, and writing up results in study reports, regulatory submissions, abstracts, posters, presentations, manuscripts, and other documents.
- Participate as a Study Team member. Function as Project Clinician. In this role the Medical Director will work closely across functions (e.g., Clinical Operations, Translational Medicine, Biostatistics, Clinical Pharmacology, CMC, etc.) to ensure the effective and efficient conduct of clinical studies to milestones, quality and budget.
- Participate in Pharmacovigilance Signaling Meetings and any safety Working Group meetings.
- Participate in or co-lead regularly scheduled and ad hoc teleconferences and meetings with clinical investigators. Participate in and contribute clinical insights and interpretations on routine calls for Phase 1 and Phase 1-2 studies where safety data are reviewed, DLT determinations are made, and dose escalation decisions are made.
- Work closely with Investigators and other site personnel, in partnership with other Development functions, such as Clinical Operations, in order to facilitate the efficient startup, conduct and close-out of clinical trials, and to answer questions from investigators and other site personnel regarding clinical and study conduct questions. In this capacity the Medical Director will help ensure patient safety, maintain appropriate adherence to the protocol, and evaluate protocol exception requests. For Investigator Meetings and startup of individual studies, the MD may develop protocol-specific materials and lead internal or external training, as appropriate.
- Support the VP Clinical Development in responding to requests from Regulatory Authorities.
Experience and Qualifications:
- RN, Pharm.D., MD. or comparable degree. BS, MS, or Ph.D. may be sufficient in the setting of significant experience performing a similar MD role in an oncology clinical research group.
- Oncology/Inflammation/Other clinical research experience as follows:
- MD – minimum 3 years in industry setting with experience in clinical research, particularly in the areas of protocol development, study conduct, and data review.
- MD – 10 years or more in an industry clinical research or medical affairs setting, that has provided experience in protocol development, study conduct, and data review. The candidate must have a proven ability to work independently, and experience in the clinical issues typically seen in oncology clinical studies.
- MD – 10 years or more in an industry clinical research or medical affairs setting, and at least 3 years in a MD role similar in scope to that described in this document. In addition, the person must have a proven track record of working independently and sound clinical decision making.
- Track record of achievement and innovation in biotech and/or pharmaceutical medicine. Demonstrated understanding of the complexities and recent developments in oncology/inflammatory diseases. Understanding of issues related to the design and performance of technologically demanding trials. Confident discussing scientific/mechanistic aspects of oncology/inflammation drug development.
- Track record of partnering with clinical leaders, translational medicine scientists, pharmacokinetics, CROs, KOLs, etc. in designing excellent clinical oncology/inflammatory disease studies and demonstrated potential to design development plans that produce both timely and good quality data.
- Strong interpersonal skills, and comfort working in a multidisciplinary, matrix environment.
- Excellent written and verbal communication skills, with demonstrated potential to present clinical data, development plans and strategies clearly and accurately to relevant audiences. Record of good mentoring and leadership experience.
- Ability to support clinical activities to milestones and budgets.
- Enthusiasm for clinical research and drug development in an industry setting.
If you are interested in joining Ribon’s team, please email your resume to [email protected]