Merck Executive Director, Clinical Safety Risk Management, Oncology (Remote) in Boston, Massachusetts
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Under the general direction of the Clinical Safety and Risk Management Therapeutic Area (CSRM TA) Lead and Vice President, Chief Safety Officer, the Executive Director for CSRM will be responsible for overall clinical risk management and safety surveillance of assigned investigational products. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across the company portfolio of products. The Executive Director will drive delivery of safety input to clinical development of oncology assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature, and post-approval use.
Responsibilities for risk communication include ensuring completeness of safety information in company core safety documents.
The successful candidate will be responsible for leading and driving safety strategy for the development of assigned products.
Collaborate with appropriate cross-functional departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio.
Lead all interactions regarding product safety issues with Research and Development governance committees and regulatory agencies.
The role works closely with CSRM Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping to develop and align processes to support departmental objectives.
Manage a team of safety physicians and have an oversight role for their products.
Required: MD, DO, or equivalent
Preferred: Board Certification
Required Experience and Skills:
Minimum 3 years clinical practice experience following post-graduate medical training
Experience in drug development
Minimum 3 years of experience in clinical safety, pharmacovigilance and/or risk management
Minimum 5 years of employment in clinical development, drug safety or regulatory or equivalent
Demonstrated organizational leadership skills, preferably in the employment areas noted above.
Excellent communication, writing and analytic skills
Preferred Experience and Skills:
- Experience managing people
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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Flexible Work Arrangements:
Not Specified, Remote Work
Valid Driving License:
Number of Openings:
Requisition ID: R196572
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