Executive Director Clinical Trial Operations jobs at Msd in Israel

Job Description

Executive Director, Clinical Research Israel

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 company’s research division’s 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 division’s 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 division’s 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:

• Bachelor’s 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

Current Contingent Workers apply

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 more}

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