Job Description

　　Global Clinical Trial Operations (GCTO) is a global organization with over 9500 people operating in 47 countries. The Clinical Sciences and Study Management organization (CSSM) is a sub-functional unit within GCTO, divided into three therapeutic clusters, with over 1000 people, and is accountable for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, including a grant budget more than $1B.

　　Key activities for this role include the strategic planning, oversight, management, and execution of HQ-sponsored trials for the assigned Therapeutic Area Section, including local registration trials and regulatory commitments. The position is also directly responsible for the technical/scientific support of all clinical research trials and programs within the defined Therapeutic Area Section.

　　Applies an in-depth understanding of Research and Development's (R&D) clinical development strategy in the implementation of short and long-term research objectives. Liaises with cross functional areas supporting clinical development including Therapeutic Area Section Heads and Senior Regulatory and Safety Executives to ensure staffing and support is consistent with development priorities. Responsible for ensuring that members of the staff are provided with appropriate vision, direction, training, and sponsorship of projects and initiatives. Ensures performance management and career development plans are implemented by direct supervisors and that the entire organization is compliant with all policies and procedures. This role is a highly cross functional and influential role with Global Clinical Development.

　　Primary Responsibilities:

　　Provide leadership to the designated Therapeutic Area Section within CSSM. This includes continual optimization of the organizational resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Identify and drive enhancements/standardization of CSSM TA deliverables and tolls/processes to increase efficiencies. Provide leadership during conduct of risk assessments and mitigation planning for priority program execution. Engagement with key vendor partners to align on strategy, execution, and delivery for the expanding Oncology portfolio.

　　Ensure the successful execution for all headquarter based patient clinical trials. Provides direction and oversight to teams in preparation for Late-Stage Development Review Committee, Operational Reviews, and Deep Dive Meetings. As CSSM has accountability for the overall success of the studies, this is achieved by defining the overall Indication, program, and study clinical operational strategies, ensuring rigorous leadership across all levels of the organization, overall study budget management and comprehensive program and study communication with all internal and external stakeholders. Ensure implementation of job-related tools and systems by staff. Ensure implementation of job-related tools and systems by staff. In addition, ensure the development of detailed study design specifications, medical monitoring of study data and summarizing results for assigned R&D clinical trials.

　　Represent GCTO and CSSM on strategic initiatives at all levels of the organization. Provide leadership to the CSSM organization as a member of the CSSM Leadership Team. Effectively manage resources to ensure appropriately skilled and high performing staffs are assigned to effectively execute on the Book of Business and achieve Global Clinical Development (GCD) and R&D objectives. Sets clear performance standards and holds self and organization accountable for achieving results.

　　Education:

　　Bachelor's Degree required with a concentration in a scientific-related discipline strongly preferred. Advanced Scientific Degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred.

　　Required Experience and Skills:

　　15+ years of relevant experience working on clinical development programs (pharma/biotech/academia/government) or equivalent combination of education and experience required.Extensive experience in the planning and execution of clinical trials with demonstrated ability to translate knowledge and expertise to areas at all levels within the R&D sphere of influence (Therapeutic Areas, Regional Operations, Data Management, Clinical Supplies, Functional Service Providers, and Vendors etc.). Demonstrated ability to effectively manage scope, time and cost of assigned projects; is business savvy and results oriented.Proven ability to lead and actively contribute to the design and implementation of cross-functional strategic, process, and improvement initiatives.

　　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.

　　Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

　　Current Employees apply HERE

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　　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 if you need an accommodation during the application or hiring process.

　　We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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　　We 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.

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　　U.S. Hybrid Work Model

　　Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

　　Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

　　Expected salary range:

　　$235,280.00 - $370,400.00

　　Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

　　Search Firm Representatives Please Read Carefully

　　Merck & 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:

　　Regular

　　Relocation:

　　No relocation

　　VISA Sponsorship:

　　No

　　Travel Requirements:

　　25%

　　Flexible Work Arrangements:

　　Hybrid

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　N/A

　　Requisition ID:R273168