Executive Director, Clinical Operations

Executive Director, Clinical Operations

22 Jul 2024
Wyoming, Cheyenne, 82001 Cheyenne USA

Executive Director, Clinical Operations

Vacancy expired!

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.The Executive Director, Clinical Operations manages all aspects of clinical trial operations in a country/ cluster of countries and is responsible for exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and Clinical Research Organization (CRO) run studies.Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The Executive Director is responsible for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV within the country/cluster. The position has multiple touch points with Global Clinical Trial Operations (GCTO) and Research & Development (R&D) staff in the US headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Global Human Health (GHH)/Global Medical Affairs (GMA).Primary Responsibilities:Provide Leadership to the country(s): 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. Adhere to our company standards and R&D / Global Clinical Development (GCD) and GCTO goals, initiatives and expectations. Participate and support the goals and objectives of the GCTO Leadership Team. Speak with “one voice” on agreed strategies.

Manage 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.

Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and if applicable the Regional Operations Center (ROC), to deliver objectives

Collaborate with Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for our company's internal clinical trial portfolio

Collaborate with Clinical Research Organization (CRO) Senior, Regional and local Leadership 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.

Support the development and management of Investigator relationships in conjunction with the R&D Therapy Areas, and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).

Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).

Represent 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 R&D objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s)

Represents the GCTO organization both internally and externally within the industry

Responsible for ensuring appropriate scientific and operational training for staff members.

Educational Requirements:Required: Master’s Degree in a life science combined with a proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations

Preferred: Advanced graduate degree (e.g., an MD, PhD, Pharm D)

CORE Competency Expectations:Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and our Manufacturing Division in a matrix organization.

Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery

A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.

Strong Communication skills requiring proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.

Strategic thinking

Behavioral Competency Expectations:High emotional intelligence

Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of our Research & Development Division, Global Clinical Development (GCD) and GCTO

Positive proven success in people management

Required Experience and Skills:10-15 years of experience 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

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 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.Residents of ColoradoClick here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.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 Supplement​OFCCP 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:No relocationVISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Remote WorkShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R193845

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Job Details

  • ID
    JC44315719
  • State
  • City
  • Full-time
  • Salary
    N/A
  • Hiring Company
    Merck
  • Date
    2022-07-22
  • Deadline
    2022-09-20
  • Category

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