I am currently partnered with a growing immune-oncology organization in Waltham, MA seeking a highly motivated and qualified Medical Director/Sr Director to join their team! This position will work closely with and report to the Head of R&D. This role will be responsible for the timely development and implementation of early clinical development plans and clinical trials across company's drug candidates in immunology-oncology indications.
The responsibilities include trial design, protocol development, monitoring medical safety, overseeing data analysis, summary, review, interpretation, and regulatory reporting. This individual will be the primary driver for the company's clinical programs and be accountable for successful trials.
RESPONSIBILITIES
- Lead the early clinical trial protocol development/amendment, inclusion/exclusion criteria, escalation and stopping rules and safety monitoring.
- Key contributor in the preparation of regulatory filings (e.g. pre-IND, IND, eCTD, etc.) and serve as a point of clinical contact to regulators' questions as needed.
- Serves as internal medical monitor, including medical coding, and keep track of all clinical trial results, particularly safety and other functions.
- Work closely with Clinical Operation team, CRO and PI to review and interpret clinical study data, including real-time adverse event monitoring, documentation such as Investigator Alert letters and SAE reports as required
- Lead in clinical advisory board meetings and investigator meetings, including preparation and delivery of presentations at national clinical conferences.
- Identify and evaluate early translational needs and issue of company's pipeline and provide strategy and direction for the management team
- Drive clinical programs with cross functional teams to effectively deliver Company objectives.
QUALIFICATIONS
- Ability to travel to Waltham, MA (hybrid schedule)
- MD or MD/PhD degree required and with US board certification highly preferred.
- 5 plus years direct early clinical trial experience preferred
- Immunology background with oncology and other disease early phase trial experience.
- Strong knowledge of clinical trial process, study design, statistics, clinical operations
- Good knowledge of FDA and ICH regulations and industry standards applicable to the trial design safety coding and reporting
- Excellent communications, such as presenting to a variety of audiences (medical, scientific, board) in a clear, credible, and engaging manner.
- Entrepreneurial, ability to operate autonomously in a fast-paced, innovative early phase company while remaining flexible, proactive, resourceful, and efficient.
Benefits
- This organization offers a competitive salary, bonus structure and stock options
- Full coverage of Medical Dental and Vision
If you are interested in the Medical Director/Senior Director Clinical Development role please don't wait to apply!
