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Director, Clinical Research Early Talent Development

  • Anywhere

Company :
Merck

Location :
Rahway, New Jersey

Expiry Date :
Fri, 26 Mar 2021 23:59:59 GMT

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Description :
Job Description nOur Clinical Research team pushes 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. nThe position manages aspects of clinical trial operations in the country and will manage execution of all interventional clinical trials and CRO run studies. Will adhere to Good Clinical Practices (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies. The position will manage and oversee a team of individuals responsible for Clinical Trial Coordination as well as New and Early Talent Development. nThe position has multiple touchpoints with Global Clinical Trial Operations (GCTO) and company Research Labs staff in our headquarters. Additionally, there are important interactions within a highly matrix-based organization. nPrimary activities: nProvide Leadership to the country: Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. nAdhere to company standards and Research Laboratory/Global Clinical Development (GCD) and GCTO goals, initiatives and expectations. nManage Clinical Operations activities and personnel within the country/cluster. Ensure that compliance, quality and timeline objectives are met for all trials executed in the country. nWork collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) nEngage with Functional Service Provider (FSP) Senior, Regional and local team to ensure adequate and appropriate resourcing for the company’s internal clinical trial portfolio nPartner with Clinical Research Organization (CRO) Senior, Regional and local team to ensure the successful implementation of fully outsourced clinical trials – Work with the Global Operations group within GCTO and Global Medical Affairs as appropriate, in site management and selection decisions nRepresent GCTO and the country on strategic initiatives at all levels of the organization. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and research laboratory objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s) nRepresents the GCTO organization both internally and externally within the industry nEnsure appropriate scientific and operational training for staff members nCore Competency Expectations: nSignificant Management background in a Clinical Trials setting with the ability to service and engage with different stakeholders within GCTO and research laboratory in a matrix organization. nManagement expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery nComplete awareness of the International Conference on Harmonization Good Clinical Practice (ICH GCP) and Global/Regional/Local regulatory requirements is needed. nStrong communication skills requiring proficiency in written and spoken English. nBehavioral Competency Expectations: nHigh emotional intelligence nStrong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, will enable and drive alignment with the goals, purpose and mission of our company’s Research Labs, Global Clinical Development (GCD) and GCTO nPositive proven success in people management nStrategic thinker nExperience: n10+ years in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation nEducational Qualifications: nRequired: Bachelor’s degree in life sciences combined with consistent contribution to and delivery of clinical trial execution nHighly Preferred: Advanced degree (e.g. MA/MS, MD, PhD, Pharm D) nWe 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. nWho we are .n We are known as Merck & Co., Inc., Kenilworth, 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. nWhat we look for .n 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. nINVENT. nIMPACT. nINSPIRE. nNOTICE FOR INTERNAL APPLICANTS nIn 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. nIf 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. nUS and Puerto Rico Residents Only: nIf you need an accommodation for the application process please email us at nFor more information about personal rights under Equal Employment Opportunity, visit: nEEOC Poster nEEOC GINA Supplementn OFCCP EEO Supplement nOFCCP Pay Transparency Rule nWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations. nSearch Firm Representatives Please Read Carefully nMerck & 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. nEmployee Status:n Regular nRelocation: nNo relocation nVISA Sponsorship: nNo nTravel Requirements: n25% nFlexible Work Arrangements: nRemote Work nShift: n1st – Day nValid Driving License: nYes nHazardous Material(s): nNumber of Openings:n 1 nRequisition ID:R96614