Sr. Medical Director, Clinical Development

Taiho Oncology, Inc.•Princeton, NJ

165d•$323,850 - $381,000•Hybrid

About The Position

This position has direct responsibility for design, execution and reporting of current and future clinical oncology trials ranging from phase 1 – 3. Assumes the medical leadership on clinical trials for Taiho Oncology, Inc. (TOI) in the USA and Europe. This position serves as a responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed. Uses medical/scientific expertise to create or support the creation of relevant clinical documents of high quality such as study concepts, study protocols and reports, investigator brochures, NDA/MAA registration documents and publications. Reviews and signs off on clinical documents related to clinical studies as outlined by the manager. Builds and maintains effective relationships with clinical key opinion leaders in various different areas of disease in which Taiho is developing drugs. Will collaborate with all department heads within TOI (Head of Clinical Research and Head of Clinical Operations) to establish operational plans and timelines for respective studies within each of the development programs for review by the SVP Clinical Development or the Chief Medical Officer. Keeps SVP Clinical Development or the Chief Medical Officer current on status of clinical trials and provides ongoing risk assessments for the study conduct and operational risks. Co-responsible with SVP Clinical Development, Project Management, Head of Clinical Research, and Head of Clinical Operations for delivering the design, conduct, and reporting of clinical trials within agreed timelines. Collaborates with Clinical Operations/trial management in vendor oversight. Continually assesses if adequate resources are available to meet clinical trial deliverables and milestones.

Requirements

Successful completion of MD training.
4-7 years combined experience in academic and/or industry oncology clinical research and drug development.
Experience as medical monitor or investigator on a clinical oncology trial.
At least 2 years in drug development industry in oncology.
Previous exposure to clinical development, regulatory and statistical activities (e.g., authoring/reviewing protocols, SAPs, IND/NDA ARs, PSURs, DSURs, IBs, ICFs, orphan drug designations, regulatory briefing documents).
Working knowledge of the drug development process in the USA and EU.
Highly detail and quality oriented.
Excellent presentation skills.
Ability to learn, integrate complex information, and communicate clinical information clearly.
Ability to understand and implement prioritization of deliverables and recognize/highlight conflicts in priorities.
A positive attitude, flexibility, and a proactive thought process.

Nice To Haves

Completion of training in a medical sub-specialty with a completed fellowship in a Hematology-Oncology program.
Hematology or Oncology Board eligibility or certification.
Clinical practice experience of a minimum of 1-3 years.
Previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND/MAA registration documents, investigator brochures, informed consent forms, orphan drug designations, regulatory briefing documents, etc.
Experience in direct interactions with US and/or EU Regulatory authorities.

Responsibilities

Design, execution, and reporting of clinical oncology trials (Phase 1-3).
Medical leadership on clinical trials in the USA and Europe.
Serve as a medical monitor or Lead medical monitor for clinical trials.
Create or support the creation of clinical documents (study concepts, protocols, reports, investigator brochures, registration documents, publications).
Review and sign off on clinical documents.
Build and maintain relationships with clinical key opinion leaders.
Collaborate with department heads to establish operational plans and timelines.
Keep leadership informed on clinical trial status and provide risk assessments.
Co-responsible for delivering the design, conduct, and reporting of clinical trials within timelines.
Collaborate with Clinical Operations/trial management in vendor oversight.
Assess resource availability for clinical trial deliverables.