Attention NJ Applicants: In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.
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 Clinical Safety and Risk Management (CSRM) Therapeutic Area (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 our 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. They will collaborate with appropriate cross-functional company departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio. They will be responsible for leading all interactions regarding product safety issues with Research & Development (R&D) 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. They will also 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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range: $285,920.00 - $450,000.00 For Washington State Jobs, a summary of benefits is listed here .
Learn more about your rights, including under California, Colorado and other US State Acts
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Employee Status: Regular
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid, Remote Work
Valid Driving License:
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 01/25/23
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