Merck Executive Director/Distinguished Scientist, Clinical Safety and Risk Management in Rahway, New Jersey
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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 Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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 Company'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 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's 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.
Education Minimum Requirement:
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 …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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 .
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at [email protected]
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R62146
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