Director/Senior Medical Director, Early Oncology Clinical Safety
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Director/Senior Medical Director, Early Oncology Clinical Safety.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Understands how to effectively apply pharmacology, chemistry and non-clinical toxicology to conduct safety surveillances.
- Assumes responsibility of the safety surveillance of combined early oncology products.
- Leads, sets the strategy, and when appropriate writes the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, and the 15-day aggregate reports.
- Utilizes current regulatory guidance for safety surveillance and authorship of safety documents.
- Analyzes, interprets, and summarizes aggregate safety data.
- Communicates the findings and interpretations of the safety data to cross-functional teams and senior management.
- Writes, reviews, and provides input independently on technical documents.
- Oversees and takes responsibility for leading the strategy as well as writing, when applicable, the key sections for periodic reports.
- Leads and sets the strategy, in collaboration with the development medical lead of study protocols and informed consents.
- Takes responsibility for implementing risk management strategies for assigned product.
- Engages, inspires, coaches and mentors team members and colleagues.
- Takes opportunities to co-author publications and participates in initiatives to continue developing and growing as a safety leader.
- Requires an M.D. or D.O. with a minimum of 2+ years of residency with patient management experience.
- A Master of Public Health degree in addition to an M.D. / D.O. is preferred.
- Must have a minimum of 5+ years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry.
- Requires experience in early oncology safety.
- Must effectively analyze and guide analysis of clinical data and epidemiological information.
- Required to effectively present recommendations / opinions, participate in healthy debates, and be open to different perspectives within a group environment, both internally and externally.
- Must have excellent writing skills, and the ability to review and provide input on technical documents.
- Required to work collaboratively with cross functional teams.
- Must have the ability to lead a matrix cross-functional team in a collaborative environment.
- Must be fluent in both written and spoken English.
- Required to evaluate and make independent decisions.
- Must have the ability to work effectively in the situation of uncertainty and complexity.
- Requires the ability to multitask and work on fast paced programs.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.