Sr. Director, Clinical Safety Risk Management Physician (Remote)
Truly remote roles are often hard to come by. Truly remote roles with exciting Immuno-Oncology companies are impossible to find… Until now.
We have partnered with a leading Immuno-Oncology organization in its search for a Sr. Director, Clinical Safety Risk Management Physician. This position will be fully remote even post-covid. This newly created role reports into the VP of Pharmacovigilance, who is an excellent mentor who will also allow you to have the autonomy to make decisions. There are tremendous opportunities to grow with the companies burgeoning portfolio of indications. Apply today to learn more!
The Sr. Director, Clinical Safety Risk Management Physician (Remote) will be responsible for:
- Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team, and other related sub-team participation, for assigned products. This may include participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
- Partners with clinical development to ensure that clinical programs will support robust safety assessment of our investigational compounds.
- The CSRM physician may work closely with a cross-functional group of experts in regulatory affairs, statistics, epidemiology and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet our global pharmacovigilance and risk management strategies for assigned products.
- Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use
- Accountable for scientific strategy for safety related documents (e.g. CTD components, RMPs, DSUR and PADERs/PBRERs) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
- Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgment in review of summary data and individual cases as well as overseeing the medical judgment of other staff.
- Responsible for the development of worldwide risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.
- The CSRM physician may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing.
- Works with Head of Safety to plan direction for function of the department, helps develop departmental and enterprise processes (as assigned).
Ideal Candidates will have:
- D., or foreign equivalent.
- Minimum 3-4 years pharmacovigilance experience working in the regulated medical products industry with a strong track record in working well with teams.
- Experience in Oncology or Immuno-Oncology.
- Experience leading a team.