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Job DescriptionOur 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.Role can be remote.We are seeking a Growth and Improvement minded Office of Senior Infectious Disease Clinical Research Director that can help drive our Strategic Operating Priorities.Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Strategic SummaryThe Senior Director reports to an Executive Director in the Infectious Disease Clinical Research Group. Anti-infective drug development has been our core mission for over 80 years. Our Clinical Research group is at the forefront of global healthcare through research and innovation to combat established and emerging pathogens. Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our medicines.Under the guidance of a supervisor, the Senior Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs in the infectious diseases (Clinical Research) group. The individual would participate in all phases of clinical trial process (mainly Phase 2-5) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual would apply an in-depth understanding of the disease under study and drug/vaccine pharmacology to the Infectious Disease therapeutic area’s clinical development strategy and the implementation of short and long-term research objectives. They would provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders. In addition, a Senior Director may lead a Product Development Team, the cross-functional team responsible for end-to-end development and lifecycle management of new or marketed drugs, and will serve as the Clinical representative to this team.Key FunctionsGeneralWork Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
Developing clinical development strategies for investigational or marketed infectious disease drugs
Planning clinical trials (design, operational plans) based on these clinical development strategies
Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Infectious Disease drugs
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
Presenting study data and program strategic plans to internal governance committees for endorsement and key program milestones
Supervise the activities of Clinical Scientists or other Clinical Directors in the execution of clinical studies
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
Assist the Senior/Executive Director in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company's and competitor's drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility
Maintain Strong Scientific Fund KnowledgeMaintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility
Goal AccomplishmentAuthor detailed development documents, presentations for internal/external audiences and scientific publications
Facilitate collaborations with external researchers around the world
Travel on company business up to about 10% of the time to manage future or ongoing clinical research projects
EducationM.D or M.D./Ph.D from a recognized school of medicine, preferably with demonstrated expertise in Infectious Diseases subspecialty
Eligibility for medical licensure and board certification preferred
With postgraduate program yielding a PharmD degree and demonstrated expertise in clinical practice or clinical research may also be considered for the position
RequiredIndustry experience in clinical research and drug development | Consideration will be given to candidates with relevant governmental/regulatory agency experience or faculty in academia with experience leading large-scale clinical research activities
Demonstrated record of scientific scholarship and achievement
Experience in clinical medicine and background in biomedical research
Excellent communication skills, both verbal and written
Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience
PreferredSpecific experience in clinical research
MDPhysicianjobs#MDPhysicianjobsWe 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 APPLICANTSIn 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.New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA SupplementOFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe 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.Residents of Colorado:Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:DomesticVISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Hybrid, Remote WorkShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R199357
