Senior Medical Director, Clinical Development

US-NJ-Princeton
Category
Clinical
Type
Regular Full-Time

Position Summary

This position has direct responsibility for design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.

Responsibilities

Responsibilities and Duties:

  • Assumes the medical leadership on clinical trials for Taiho 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.
  • Performs other duties as required.

Qualifications

 

Educational Requirements:

  • Successful completion of MD training mandatory; completion of training in a medical sub-specialty with a completed fellowship in a Hematology-Oncology program preferred.
  • Hematology or Oncology Board eligibility or certification preferred.
  • Clinical practice experience of a minimum of 3-5 years preferred.

 

Experience:

  • 7-10 years combined experience in academic and/or industry oncology clinical research an drug development, including experience as medical monitor or investigator on a clinical oncology trial.
  • At least 2 years in drug development industry in oncology and with 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 AR, NDA AR, PSUR, DSUR, IB, ICF, orphan drug designations, regulatory briefing document, etc. is preferable.

 

Other Skills and Abilities:

  • Working knowledge of the drug development process in the USA and EU is required.
  • Experience in direct interactions with US and/or EU Regulatory authorities is highly preferred.
  • Highly detail and quality oriented.
  • Excellent presentation skills.
  • Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
  • Ability to understand and implement prioritization of deliverables as well as recognize and highlight conflicts in priorities.
  • A positive attitude, flexibility and a proactive thought process.

 

Language Skills:

  • Ability to read, analyze and interpret scientific and technical information and data.
  • Excellent English communication skills, both verbal and written.

 

Mathematical Skills:

  • Ability to work with mathematical concepts such as probability and statistical measures.

 

Reasoning Ability:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical information and deal with several abstract and concrete variables.

 

Computer Skills:

  • Strong computer skills in MS Office products.

 

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
  • The employee is occasionally required to walk.
  • Must be able to travel domestically and internationally on a reasonably frequent basis (approx. 15-20% of time including some weekend travel).

 

Work Environment:

  • The noise level in the work environment is usually quiet. The noise level in the office work environment is usually quiet.
  • Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The incumbent in this position may be required to perform other duties, as assigned.

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