Clinical Safety Risk Management Physician, Oncology
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.
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
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 Territory Representatives interact face to face with our customers, understand their needs and consult to offer the right solutions. We work collaboratively in Field Sales Teams and play a critical role in supporting our customer centric business model.
The Sales Representative is a key member of the field sales team and plays a critical role in supporting our customer centric business model. This position is responsible for working in their respective territory to understand and identify customer needs, by selling our Animal Health products, supporting pull-through activities relative to the customer strategy, and ensuring that Animal Health is viewed as bringing value and technical innovations aligned to our strategic focus the Science of Healthier Animals. In addition, the Sales Representative demonstrates an understanding of the resources available across Animal Health and our Distribution Partners.
Key responsibilities may include, but are not limited to:
• Communicates about product in a way that's meaningful and relevant to each individual customer; customizes discussions and interactions based on understanding of customer's needs
• Primary point of contact for assigned customers, meets with key personnel/decision makers to understand practice structure, business model, key influencers, customer needs and identifies business opportunities.
• Develop customer strategy - outlining strategy for interactions/relationship, solutions, partner involvement and potential offerings for customer resulting in sales opportunities and account sales growth of Animal Health products and services.
• Develop territory and specific account plans for all assigned customers. Partners with National Account Managers, Corporate Account Team, and Distribution Field Partners to maintain strong focus on accounts to drive sales growth.
• Work collaboratively across all species teams to foster our approach to enhance knowledge of the entire AH product portfolio.
• Shares with other team members within the region to foster growth and development within the team.
• Analyze sales results on a regular (monthly) basis and manage expenses within budget guidelines.
• Identifies and selects programs/services available within Animal Health’s available resources to address customer needs and provide education & training opportunities to accounts.
• Works with leadership and Field Technical Services to develop and deliver relevant offerings that address desired customer needs.
• Develop current understanding of Animal Health products, industry trends and competitor landscape, business model, key influencers/ network structure and make information available to relevant stakeholders and to influence sales trends.
• Articulates and communicates relevant customer, industry, product, and market trends appropriately through the organization.
• Responsible for developing and meeting learning and development objectives agreed upon with leadership.
Education Minimum Requirement:
• Bachelor's Degree
Required Experience and Skills**:
• Familiarity with the Ruminant Industry
• Excellent interpersonal/communication and presentation skills
• Ability to adapt to a changing environment
• Proficient computer skills including working knowledge of Word, Excel and PowerPoint and the ability to use an iPad.
• Ability to work independently and also as part of a team
• Ability to travel overnight and some weekend activity
Preferred Experience and Skills:
• Past Internships
• Animal Judging Teams, 4H, FFA, etc.
• Honors programs, Catalyst programs, etc.
• Fluency in Spanish is preferred but not required.
Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.
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.
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.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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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.
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