Director, Clinical Science and Diagnostics

Director, Clinical Science and Diagnostics

PTC Therapeutics

Zug, Switzerland

Job Description:

The Director, Clinical Science and Diagnostics (CSD) is a position within Medical Affairs supporting disease diagnosis, diagnostic methods, and strategic initiatives to facilitate early, accurate diagnosis, across all programs of the PTC portfolio within the assigned region.

Clinical expertise for disease state, clinical presentation, and differential diagnosis of the diseases of interest in PTC’s portfolio will allow the CSD to evaluate and address regional diagnosis gaps. The CSD will develop strategic and innovative diagnosis initiatives to complement the PTC portfolio, supporting PTC programs from clinical trial through commercialization. The CSD will partner with the medical and commercial field teams to support early disease recognition and diagnosis by health care providers.

The incumbent works cross-functionally with internal Clinical and Commercial colleagues and external collaborators on solutions for Clinical Science and Diagnostic related issues.

The Director, Clinical Science and Diagnostics ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

  • Evaluates diagnosis flow and potential gaps across PTC portfolio programs;
  • Develops strategic and innovative diagnosis initiatives to facilitate early and accurate diagnosis;
  • Partners with KOL clinicians and diagnosticians to identify diagnostic gaps and opportunities for improvement in diagnostic workup;
  • Partners with marketing to develop and refine diagnostic pathways;
  • Evaluates clinical, biochemical, and molecular diagnostic methods including current Standards of Care and potential evolution of Standards of Care;
  • Identifies and qualify enriched populations for testing. Lead efforts to pilot testing programs as appropriate;
  • Generates data to support scientific publications regarding diagnostic testing and potential screening of at-risk populations as appropriate;
  • Identifies and maintain relationships with regional diagnostic laboratories, laboratory directors, and KOL diagnosticians;
  • Performs medical reviews of marketing materials to support early diagnosis (diagnostic pathway, clinical presentation, differential diagnosis, common misdiagnosis) and supporting materials for testing (order form/website, kits, requisition forms);
  • Maintains in depth understanding of PTC pipeline programs and clinical trials to support the diagnosis efforts for each program;
  • Partners with GSMS to plan budget for testing programs;
  • Educates and partner with field teams (medical and commercial) to expand reach of diagnosis messaging;
  • Maintains a thorough awareness of medical/clinical, regulatory, compliance and quality issues and processes as they apply to the PTC therapeutic areas and adheres to, and supports, the standards established by the company. Performs other tasks and assignments as needed and specified by management.

Minimum level of education and years of relevant work experience:

  • Requires a Bachelor’s degree in a scientific discipline and a minimum of 8 years progressively responsible experience in a pharmaceutical, biotechnology, healthcare or related environment;
  • Advanced degree in a scientific discipline preferred;
  • Relevant experience in rare disease and/or gene therapy encompassing patient identification and establishment of KOL networks is highly desirable.

Special knowledge or skills needed and/or licenses or certificates required:

  • Understanding of biochemical and molecular diagnostic methods;
  • Experience working with KOLs, clinicians, HCPs, payors and/or academic institutions establishing/maintaining relationships and scientific/medical credibility;
  • Demonstrated success in interpreting scientific data and presenting research information to scientists and HCPs;
  • Proficiency with Microsoft Office;
  • Excellent verbal and written communication and skills;
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members;
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines;
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Special knowledge or skills and/or licenses or certificates preferred:

  • Experience working with regional diagnostic laboratories;
  • Understanding of regional/country specific regulatory requirements for bio-sample shipping and analysis;
  • Experience supporting an orphan, rare disease and/or specialized drug(s).

Travel requirements:

  • 50-60%.

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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