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Job Details

Clinical Research Director

Company: Edelway Switzerland AG
Location: Basel area
Reference: SJ-02
Closing Date: 17 Aug 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Edelway is a pan-European Pharma Consultancy. One of our best clients, a global, pharmaceutical company based in Basel Area, Switzerland is currently looking for experienced Clinical Research Director.

Requirements:

  • This position is responsible for exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and CRO run studies. Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is responsible 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 I/II through III/IV within the country. The position has multiple touch points with GCTO and Research Labs staff in the US headquarters, or in the Europe Global Clinical Development (GCD) regional office. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Global Human Health (GHH)/Global Medical Affairs (GMA).

Key Responsibilities, but not limited to:

  • Leadership of people, projects and productivity aligned with HQ and Senior Leadership.
  • People management. Recruitment, development, training, motivating and retaining staff.
  • Project Delivery. All aspects of project delivery, including budget and resource management to the highest quality standards. Participation and preparation of information for Operational Reviews and Milestone delivery.
  • Business Acumen. Prepare and manage budgets with close collaboration with Finance and GCTO Leadership. Manage Country budget to agreed targets.
  • Manage all aspects of quality, inspection preparedness, TMF, inspection preparation and defense as well as audit hosting, responding and effective CAPA management.
  • Communication. Clear, aligned and effective verbal and written communication is expected to inform and manage the local organization as well as the region and headquarters staff.
  • Partnership. Partner with all functions within GCTO, as well as key collaborative groups and functions such as Clinical Supplies, QA and Regulatory.

Primary Activities/Responsibilities:

  • Provide Leadership to the country: Build the best team and chart the course.
  • This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies.
  • Manage Clinical Operations activities and personnel within the country. Ensure that compliance, quality and timeline objectives are met for all trials executed in the region.
  • Work collaboratively in a matrix organization with all groups within GCTO, especially with the Regional Operations Center (ROC), Clinical Sciences and Study Management (CSSM) and Regional Clinical Quality Managers (RCQMs), to deliver objectives.
  • Collaborate with Functional Service Provider (FSP) Senior and Regional Leadership to ensure adequate.
  • Collaborate with Clinical Research Organization (CRO) Senior and Regional Leadership to ensure the successful implementation of fully-outsourced clinical trials.
  • Work with the Global Operations group within GCTO and Global Medical Affairs as appropriate, in site management and selection decisions.
  • Support the development and management of Investigator relationships in conjunction with the Therapy Areas, Europe Global Clinical Development and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
  • 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).
  • Represent GCTO and the Regions on strategic initiatives at all levels of the organization. Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO, GCD, and objectives. Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s).
  • Responsible for ensuring appropriate scientific and operational training for staff members.

Qualifications:

  • An advanced graduate degree (e.g., an MD, PhD, Pharm D, MS,) is preferred or, at minimum, a Master’s Degree in a life science combined with a proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations. Business and financial management skills are an added advantage (e.g. MBA).
  • 10-15 years of experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
  • Strong Leadership skills 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 Research Labs, Global Clinical Development (GCD) and GCTO.
  • Significant Management experience in a Clinical Trials setting (see above), with the ability to service and collaborate with different stakeholders within GCTO 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 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.

 

If this sounds like your next challenge please send us your CV at pharma@edelway.com

Apply for this job: Clinical Research Director

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

Switzerland
Tel:  +41 58 717 7000
Website:  Visit Our Web Site

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