Clinical Safety Risk Management Physician, Oncology
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the general direction of an Executive Director, Oncology, the Clinical Safety and Risk Management (CSRM) Senior Principal Scientist is a leader in drug safety and is responsible for overall clinical risk management and safety surveillance of assigned investigational and marketed drugs.
Key responsibilities include but are not limited to the following:
• Support product development activities via Risk Management and Safety Teams and Product Development Teams and other related sub-team participation, including participation in internal and joint internal/external research project teams relevant to the development of new compounds and the further study of marketed compounds.
• The CSRM Senior Principal Scientist may work closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation.
• Duties include all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use and ensuring completeness of safety information in worldwide package circulars.
• Serves as a clinical safety expert to oncology early development teams and contributes to development of clinical strategy and transition of compounds into early phase development. Identifies safety risk/issues and provides recommendations to mitigate. Early compound clinical studies range from first-in-human Phase I, proof of concept Phase I/II and entry registrational studies.
• Provides safety assessment of in licensing/due diligence opportunities of development and marketed projects.
• Responsible for safety surveillance activities such as safety signaling reviews, using medical judgment in review of individual cases as well as overseeing the medical judgment of other staff.
• Risk management activities such as contributing to recommendations for pharmacovigilance actions and making recommendations for labeling.
• Ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
• Analyzing and summarizing the findings from available safety data to support decisions.
• The CSRM Senior Principal Scientist may supervise the activities of CSRM Staff in the execution of safety data analysis and medical writing.
• Responsible for the development of worldwide post-market risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.
Education Minimum Requirement:
• MD/DO or equivalent
Required Experience and Skills:
• Minimum 3 years clinical experience
• Experience in drug safety, pharmacovigilance and/or risk management
• Industry experience in both the investigational and post-marketing environments
• Excellent written and verbal communication skills as well as analytic skills
Preferred Experience and Skills:
• Board certification is highly desirable
• Oncology experience
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Drug Safety Surveillance (MD)
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 6
Shift (if applicable): N/A
Hazardous Materials: no
Company Trade Name: Merck