Job Description 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. Clinical Sciences & Study Management (CSSM) is building the world’s best R&D team for new medicines—and you can help make us even better. Tasks:
Accountable for the clinical/scientific execution of clinical protocol(s)/program.
Lead for all scientific aspects of the implementation and conduct of clinical studies (e.g, Scientific Advisory Committee [SAC], Data Monitoring Committee [DMC], Adjudication, medical monitoring).
Serves as the CSSM scientific lead on the clinical trial team (CTT).
Collaborates with the Medical Writer on clinical/scientific and regulatory documents and Study Manager on study deliverables.
Builds talent and capabilities of junior team members through proactive coaching, mentoring and developmentopportunities.
May include management of direct reports including assignment of resources, professional development and performance management.
Degree in the Life Sciences or significant experience in clinical development (> 15 years)
Bachelor’s degree with 11+ years’;
or MS with 8+ years’;
Pharmaceutical and/or clinical drug development experience.
Excellent oral (including presentation) and written communication, and computer/database management skills.
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.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. INVENT. IMPACT. INSPIRE. 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.If you need an accommodation for the application process please email us at firstname.lastname@example.orgFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & 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. Employee Status: RegularRelocation: No relocationVISA Sponsorship: Travel Requirements: 10%Flexible Work Arrangements: TelecommutingShift: 1st - DayValid Driving License: Hazardous Material(s): Number of Openings: 1Requisition ID: R51812