Executive Director, Clinical Safety and Risk Management, Oncology ( MERCUSR83864ENUS)
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.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are 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 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 Research & Development's 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.
- He/She will collaborate with appropriate cross-functional our Company's departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio.
- He/She will be responsible for leading all interactions regarding product safety issues with Research & Development governance committees and regulatory agencies.
- This senior 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.
- He/She also will manage a team of safety physicians and have an oversight role for their products.
- Required: MD, DO, or equivalent
- Preferred: Board Certification
- 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
- Experience managing people
Who we are …
We are known as Merck & Co., Inc., Kenilworth, 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 …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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