Infinity Pharmaceuticals

Senior Medical Director, Clinical Development (Oncology)

US-MA-Cambridge
Job ID
2017-1094
# of Openings
1
Category
Clinical Development

Overview

The Sr. Medical Director, Clinical Development will play a key role in the development of IPI-549, a first-in-class immuno-oncology drug candidate.  The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of clinical stage programs relating to the treatment of solid tumors with a focus in immuno-oncology.  The position will report to the SVP, Clinical Development.

 

The Sr. Medical Director is responsible for the day to day clinical trial activities and for ensuring that all studies are conducted with the highest level of ethical and safety standards and compliant with GCP and all regulatory policies.  Duties include primary interactions with investigators and global medical monitors, functioning as the medical representative on the integrated project team and providing medical consultations as needed across the Infinity portfolio of products and studies.

 

This role will also allow the Sr. Medical Director to be involved and gain expertise in Business Development and investor-related activities.

Responsibilities

  • Contribute to the clinical development strategy, including creating innovative strategies and clinical development plans to support global registration efforts and implementing operational plans for various malignancies.
  • Serve as global medical monitor for one or more trials in various phases of development, including Phase 1 safety, dose and signal finding, Phase 2 proof-of-concept and Phase 3 registration trials.
  • Review all individual adverse experience reports for accuracy and clinical importance and characterize their relationship to the study drug, severity and seriousness; work closely with other functions to provide accurate reports to the FDA or other regulatory agencies.
  • Review data listings, laboratory data and patient safety and efficacy data to establish the presence or absence of abnormal trends and follow up as appropriate.
  • Leads or supports the preparation of clinical protocols, integrated clinical and statistical summary reports, clinical sections included in various regulatory submissions (IND, NDA, MAA, regulatory response documents, etc.) and peer-review publications for national and international meetings and/or journals.
  • Present findings internally and externally (such as investigator meetings, regulatory agency meetings) acting as a spokesperson for Infinity relating to the trial/indication.
  • Provide medical insight to inform program and/or project investment decisions.
  • Support various meetings with external experts, advisors and business development teams.

Qualifications

  • M.D. with board certification (or board equivalent) in medical oncology.
  • At least 5 years of drug development industry experience with at least 3 years in oncology-related clinical research. Early phase development and immuno-oncology experience preferred/desirable.
  • Diplomacy and professionalism; ability to build key relationships easily across all levels of the company; ability to influence without conflict, lead change and manage resistance to change.
  • Able to work with a partner (i.e. industry partner)
  • Capable of highly independent work as well as being a team player and role model.

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