Merck Hiring for Clinical Research Director – General Medicine/Primary Care at Lincoln, Nebraska Full Time

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.

The position manages all aspects of clinical trial operations in a country and will manage exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature 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 the trial quality, audit responses and the completion of Corrective Action and Preventive Action (CAPAs).

The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across all phases within the country. The position has multiple touchpoints with Global Clinical Trial Operations (GCTO) and company Research Labs staff in our 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 Human Health/Global Medical Affairs (GMA).

Primary activities:

• Provide Leadership to the country(ies): 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 company standards and Research Laboratory/Global Clinical Development (GCD) and GCTO goals, initiatives and expectations.

• 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).

• Engage with Functional Service Provider (FSP) Senior, Regional and local team to ensure adequate and appropriate resourcing for the company’s internal clinical trial portfolio.

• Partner 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.

• Develop and manage Investigator relationships in conjunction with the research laboratory 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.).

• Manage clinical audit outcomes, working closely with the Quality Assurance 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 research laboratory 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.

• Ensure appropriate scientific and operational training for staff members.

Core Competency Expectations:

• Significant 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.

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

• Complete awareness of the International Conference on Harmonization Good Clinical Practice (ICH GCP) and Global/Regional/Local regulatory requirements is needed.

• Strong communication skills requiring proficiency in written and spoken English.

Behavioral Competency Expectations:

• High emotional intelligence.

• Strong 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.

• Positive proven success in people management.

• Strategic thinker.

Experience:

• 10+ 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.

Educational Qualifications:

• Required: Bachelor’s degree in life sciences combined with consistent contribution to and delivery of clinical trial execution.

• Highly Preferred: Advanced degree (e.g. MA/MS, MD, PhD, Pharm D).

#EligibleforERP

MRLGCTO

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 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.

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.

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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:

Remote Work

Shift:

1st – Day

Valid Driving License:

Yes

Hazardous Material(s):

No

Number of Openings:

1

Requisition ID: R186276