Executive Director, Clinical Trial Operations
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Job Description
Job Description
Executive Director Clinical Research Israel
Our Clinical Research team pushes 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.
As an Executive Director of Clinical Research you will be the Clinical Operations lead for Israel responsible for the execution of all Clinical Trials in scope for operations. You will be a key player and take an active role in shaping the clinical research environment representing our Clinical Operations in front of Regulators Research Institutions and Industry Associations. As part of the leadership team of Non-EU EMEA Clinical Operations you will contribute to designing and driving the strategy for the region and will represent the cluster and the region at various internal fora.
As a leader you will act as a role model to create an empowering compliant collaborative and innovation-focused work environment. You will manage a team of Directors and Associate Directors who have direct reports in country and will be responsible for ensuring trial quality and audit/inspection responses and completion of CAPAs. You will ensure a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV within the cluster. The position has multiple touch points with the Global Clinical Trials Organisation and Research and Development colleagues in the US. Additionally you will have important interactions with inter alia Quality Assurance Finance Regulatory Clinical Supplies legal Global Medical Affairs (GMA) and European Clinical Development in a highly matrix-based organization with some interfaces with Global Human Health (GHH).
You will ensure adherence to GCP local and global policies and procedures to conduct high-quality inspection ready clinical studies whilst being accountable for trial quality audit responses and completion of CAPAs. You will ensure a single point of contact for managing clinical trial execution in all its aspects across phases in scope of Global Clinical Trial Operations.
In this role you will:
- Lead the Israel Clinical Trial Operations leadership team leading strategic development to deliver clinical trials as per our growing global clinical research pipeline requirement
- Be the strategic country and 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 teams to effectively deliver the study portfolio across our therapy areas to achieve on our objectives
- Lead the strategic development and management of institutional & investigator relationships in conjunction with our companys research divisions Therapy Areas
- Work with our regional and global colleagues developing and executing the Clinical Trial Operations strategy for country - such as Industry associations
Lead and manage the Israel Clinical Trials Organisation:
- Recruit hire proactively manage and develop talent in addition to creating an empowering compliant collaborative and innovation-focused work environment
- Proactively identify new opportunities and gaps to support emerging needs and addresses them by reallocating and training of existing staff and/or external recruitment
- Build a culture of quality and compliance through training oversight and collaboration
- Oversight to ensure appropriate scientific and operational training for staff members
Lead and oversee:
- Clinical Trial Operations and research divisions goals initiatives and expectations
- Development and delivery of company standards
- Activities of all cluster level teams programs and studies
- Country level operational study budgets
- Regulatory Inspections and internal audits; responding to inquiries by health authorities ethics committees and internal auditors compliance Regulatory Pharmacovigilance (PV) and Medical Affairs
- Responsible and supports development of audit responses and completion of CAPAs.
Collaborate Support and Engage Key External Stakeholders:
- Functional Service Provider (FSP): Senior Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio
- Support the development and management of Investigator and operational relationships in conjunction with all research divisions 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 etc.)
- Drive change by shaping the external environment
Quality / Compliance Adherence / Standard:
- Ensure that compliance quality and timeline objectives are met for all trials executed in the cluster.
- Sets clear performance standards and holds self and organization accountable for achieving results.
- Work collaboratively in a matrix organization with all groups within Clinical Trials especially with Clinical Sciences and Study Management in our US headquarters Clinical Quality Managers 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.
To be successful in this role you will need:
- Bachelors degree in Science or equivalent healthcare experience is required advanced degree (e.g. MD PhD Pharm D MS MBA) is preferred.
- Significant experience in Clinical Trials.
- Proven leadership experience preferably in the pharmaceutical or biotech company.
Competency Expectations:
- Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders in a matrix organization.
- Strategic thinking
- Management expertise should cover management of budget travel resources headcount processes (and controls) productivity quality and project delivery.
- A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
- Strong Communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication.
- 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 company.
- Positive proven success in people management
We are 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.
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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Budget Management Business Clinical Research Clinical Research Organizations (CRO) Management Clinical Risk Management Clinical Site 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 Management Process Medical Affairs Medical Law Mentorship People Leadership Pharmacovigilance Regulatory Requirements 4 morePreferred Skills:
Job Posting End Date:
07/1/2025*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
