Executive Director, Clinical Operations Brazil
Executive Director, Clinical Operations Brazil
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Job Description
Job Description
The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trials Operations (GCTO).
Adherence to Good Clinical Practice (GCP) local and global policies and procedures to conduct high-quality inspection ready studies is essential. The position is accountable 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 in scope of GCTO within the country/cluster.
The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.
CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities:
Supports the regional GCTO leadership team leading strategic development of their country /cluster to deliver clinical trials as per global clinical research pipeline requirement
Strategic country / cluster representative for initiatives at all levels of the organization
Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO Global Clinical Development (GCD) and our Research & Development Division objectives
Leads strategic development and management of institutional & investigator relationships in conjunction with our Research & Development Division / GCD Therapy Areas and when appropriate Human Health
Working with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associations
Leadership and Management of the GCTO country / cluster Organization:
Recruits and hires talent
Proactively manages and develops talent
Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment
Creates an empowering compliant collaborative and innovation-focused work environment
Builds a culture of quality and compliance through training oversight and collaboration
Oversight to ensure appropriate scientific and operational training for staff members.
Clinical Operation Management:
Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster.
Leadership and oversight of the following:
Research & Development Division / GCD / GCTO goals initiatives and expectations
Development and delivery of company standards in given geography
Activities of all cluster/country level GCTO team & all programs and studies
Approved administrative budget to support GCTO team (e.g. salaries & travel)
Country level operational study budgets
Regulatory Inspections and internal audits; responding to inquiries by health authorities ethics committees and internal auditors in conjunction with CCQM compliance Regulatory Pharmacovigilance (PV) and Medical Affairs
Responsible and supports development of audit responses and completion of CAPAs.
Collaborates and supports:
Functional Service Provider (FSP) Senior Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio
Clinical Research Organization (CRO) Senior Regional and local Leadership to ensure the successful conduct of outsourced clinical trials
Engagement With Key External Stakeholders
Supporting Management and the clinical operations of studies managed by GCTO
Support the development and management of Investigator and operational relationships in conjunction with all our Research & Development 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 Key Opinion Leaders (KOLs) etc.).
Quality / Compliance Adherence / Standard:
Ensure that compliance quality and timeline objectives are met for all trials executed in the country.
Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPIs)
Work collaboratively in a matrix organization with all groups within GCTO especially with Clinical Sciences and Study Management (CSSM) Clinical Quality Managers (CQMs) and Regional
Operations Teams to deliver objectives
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).
Qualifications Skills & Experience
CORE Competency Expectations:
Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and Research & Development 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 International Conference on Harmonisation Good Clinical Practice and Global/Regional/Local regulatory requirements is required.
Strong Communication skills requiring proficiency in written and spoken English and preferably local language Portuguese. The incumbent must be competent and effective in written and verbal communication.
Strategic thinking
High emotional intelligence
Strong leadership that will attract motivate inspire develop and retain talented addition Leadership skills that enable and drive alignment with the goals purpose and mission of our our Research & Development Division Global Clinical Development (GCD) and GCTO
Positive proven success in people management
Educational Requirements
Required:
Bachelors degree in Science or equivalent healthcare experience
Preferred:
Advanced degree (e.g. MD PhD Pharm D MS MBA)
Location office-based : São Paulo/Brazil
Extent of Travel up to 30%
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 anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.
Required Skills:
Adaptability Adaptability Budget Management Clinical Operations Clinical Quality Management Clinical Research Organizations (CRO) Management Clinical Risk Management Clinical Site Management Clinical Supplies Management Clinical Testing Clinical Trial Planning Clinical Trials Logistics Clinical Trials Monitoring Clinical Trials Operations Communication Cross-Cultural Awareness Ethical Standards Good Clinical Practice (GCP) ICH GCP Guidelines Leadership Management Process Mentorship People Leadership Pharmacotherapeutics Pharmacovigilance 4 morePreferred Skills:
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Current Contingent Workers apply 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:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
NoJob Posting End Date:
10/14/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
