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Job Details

Global Program Clinical Head

Company: CTC Resourcing Solutions
Location: Basel
Reference: 895741-P
Closing Date: 20 Mar 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds.

Requirements:

Main Responsibilities

  • Leads the Global Clinical Team, represents Clinical Development on the Global Program Team
  • May serve as the Clinical Development Representative to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point
  • May support Business Development & Licensing activities
  • Leads the development and execution of the clinical strategy. Develops an endorsed Integrated Development Plan in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs
  • Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers) with high quality and consistency. Supports registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, clinical benefit-risk assessment for license renewals) for the compound(s)
  • Together with Patient Safety, ensures continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance. Serves as a core member of the Safety Management Team
  • As the medical expert, leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Medicine, Global Medical Affairs, Marketing, Health Economics & Outcomes Research), and internal decision boards
  • Supports with leading the peer-review of IDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution
  • May contribute to development of TA strategies
  • Plans and executes publication and clinical communication strategy in coordination with Global Medical Affairs and Medical Writing, and provides input into key external presentations
  • Drives scenario development for Clinical Development to support decision analysis and optimal resource allocation in program(s)
  • Ensures career development of program reports through active participation in the performance management, talent review, and succession planning processes. Provides on-boarding, coaching, and/or mentoring support; develops and fosters Clinical Development culture
  • Responsible for medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
  • Leads or serves on global process improvement work streams, act as Subject Matter Experts for standard operating procedures or trainings, and/or contributes to other cross-functional or Clinical Development line function initiatives

Qualification / Experience

  • MD or equivalent (preferred), PhD, or PharmD degree required.
  • ≥6 years (MD or equivalent)/ ≥ 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
  • Advanced knowledge of assigned therapeutic area required, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process
  • Experience with submissions and health authorities required 
  • Demonstrated ability to establish strong scientific partnership with key stakeholders 
  • Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry 
  • ≥ 5 years people management experience required, this may include management in a matrix environment 
  • Considerable organizational awareness including significant experience working cross-functionally and in global teams 
  • Excellent management, interpersonal, communication (both written and oral), and problem solving skills 
  • Excellent negotiation and diplomatic skills
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Apply for this job: Global Program Clinical Head

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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