Clinical Research Director

Job Description

The Clinical Research Director serves as the Clinical Operations lead for a country or cluster of countries and is responsible for the execution of all clinical trials within the scope of the Global Clinical Trial Operations country organization.

This leader ensures trials are conducted to high quality standards and are inspection ready in accordance with Good Clinical Practice guidelines as well as local and global policies and procedures.

The role is accountable for trial quality audit responses and completion of corrective and preventive action plans. The Clinical Research Director provides a single point of contact for clinical trial execution across all studies and phases within the assigned country or cluster and collaborates broadly across the organization depending on country and study needs.

Key responsibilities
Strategic leadership
Partner with regional leadership to shape and deliver the country or cluster strategy that meets the global clinical research pipeline needs.
Represent the country or cluster in strategic initiatives across all levels of the organization.
Build and lead a high-performing team with the right capabilities to deliver the clinical portfolio across therapeutic areas and achieve agreed objectives for Global Clinical Trial Operations Global Clinical Development and the companys Research Laboratories.
Lead the strategic development and management of relationships with institutions and investigators in partnership with Global Clinical Development and the companys Research Laboratories therapy area teams and when appropriate with Human Health colleagues.
Co-develop and execute the Global Clinical Trial Operations strategy for the country or cluster in collaboration with regional and global colleagues including engagement with industry associations.

People and organizational leadership
Recruit hire and retain top talent.
Proactively develop and manage team members through coaching feedback and performance management.
Identify capability gaps and emerging needs; address them via resource reallocation targeted training and/or external hiring.
Foster an empowering compliant collaborative and innovation-focused culture.
Builds a culture of quality and compliance through training oversight and cross-functional collaboration.
Ensure appropriate scientific and operational training for all staff.

Clinical Operations Management
Ensures a single point of accountability for end-to-end clinical trial execution across all studies and phases within the country or cluster.
Provide leadership and oversight of:
o Objectives and initiatives for the companys Research Laboratories Global Clinical Development and Global Clinical Trial Operations.
o Development and deployment of company standards within the assigned geography.
o Activities of country/cluster clinical operations teams across all programs and studies.
o Approved administrative budgets (e.g. salaries travel) and country-level operational study budgets.
o Regulatory inspections and internal audits; coordinate responses to health authorities ethics committees and internal auditors in partnership with Country Clinical Quality Management Compliance Regulatory Affairs Pharmacovigilance and Medical Affairs.
o Development of audit responses and timely completion of corrective and preventive action plans.

Collaborate with:
o Functional Service Provider senior regional and local leaders to ensure appropriate resourcing for the internal clinical trial portfolio.
o Clinical Research Organization senior regional and local leaders Support study management and clinical operations for trials led by Global Clinical Trial Operations.

Engagement With Key External Stakeholders

Build and manage investigator and institutional relationships in partnership with therapy area teams and when appropriate Human Health colleagues.
Contribute to program life-cycle management through effective study allocation and execution including prioritization and collaboration with key opinion leaders.
Quality compliance and standards
Ensure all trials in the country meet compliance quality and timeline objectives.
Set clear performance standards and hold self and team accountable for results; embrace Global Clinical Trial Operations metrics and key performance indicators.
Work collaboratively in a matrix environment with groups across Global Clinical Trial Operations especially Clinical Sciences and Study Management Clinical Quality Managers and Regional Operations teams to deliver objectives.
Take responsibility for clinical audits working closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council.

Qualifications Required
Bachelors degree in a scientific discipline or equivalent healthcare experience.
Significant management experience within clinical trials with demonstrated ability to serve and collaborate with diverse stakeholders in a matrix organization (e.g. Clinical Operations Global Clinical Development Research Laboratories).
Proven expertise managing budgets travel resources headcount processes and controls productivity quality and project delivery.
Comprehensive understanding of International Council for Harmonisation Good Clinical Practice guidelines and global regional and local regulatory requirements.
Strong written and verbal communication skills in English; proficiency in local language preferred.
Strategic thinking capability and sound decision-making.

Preferred
Advanced degree (e.g. Medical Doctor Doctor of Philosophy Doctor of Pharmacy Master of Science Master of Business Administration).

Behavioral competencies
High emotional intelligence.
Strong inspirational leadership that attracts motivates develops and retains talent.
Demonstrated success in people management and in driving alignment with the goals purpose and mission of the companys Research Laboratories Global Clinical Development and Global Clinical Trial Operations.

Experience
510 years of experience in clinical trial operations gained in hospitals or research institutions recognized clinical trial vendors reputable contract research organizations and/or sponsor environments spanning multiple phases multiple therapeutic areas and diverse study types from initiation to closeout including regulatory submission and inspection preparation.
3 years of people management experience.

Role context and complexity
Scope typically covers a mid-sized country or a mid-complexity geography considering factors such as:
o Country/affiliate size and team size
o Product portfolio and clinical pipeline
o Local research ecosystem and volume of local data generation and investigator-initiated research
o Market access and healthcare policy environment

Required Skills:

Preferred Skills:

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