Executive Director, Clinical Operations

Job DescriptionThe **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 (KPI’s)* 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 staff. In 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:* Bachelor’s 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 another’s 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 more}**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**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
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