Medical Program Director (Clinical Science Leader)

Medical Program Director (Clinical Science Leader)

Sobi

Basel or Stockholm

Key Responsibilities:

  • Overall medical responsibility in appointed clinical projects.
  • Responsible for IB’s, protocols and reports from a medical legal perspective.
  • Responsible for medical parts in regulatory documents.
  • Ensure an appropriate and continuous medical risk/benefit assessment.
  • Execute a risk minimization at all stages to secure a sound and ethical development of a safe drug product.
  • Establish the Clinical Development Plan (CDP).
  • Identify and coordinate contacts with external consultants and clinical experts.
  • Establish relevant external advisory boards, responsible for content.
  • Support and contribute to overall project deliverables.
  • Ensure that productive, innovative and high quality development is performed.
  • Be the internal and external spokesperson for medical aspects in a given project.
  • Secure the Benefit evaluation in Benefit: Risk team in partnership with Drug Safety.
  • Provides medical review and contribution to applicable Regulatory, and Drug Safety document.

Qualifications:

  • Medical Doctor.
  • Medical & Scientific insight within immunology.
  • Minimum 5 years of pharmaceutical industry experience.
  • Clinical and academic experience.

Skills and Competencies:

  • Excellent communication and presentation skills.
  • Initiative, results oriented and delivery focus.
  • Engaged, driven, analytical.
  • Collaborative with experience from working in clinical study team.
  • Experience from FDA and EMA interactions is a plus.
  • International and/or global HQ experience with track record in virtual communication, engagement and leadership.
  • Team player with strong interpersonal skills, interact respectfully with people of different cultural, seniority and functional backgrounds.
  • Flexible and able to operate in a quickly changing environment.
  • Prioritization and time management skills.
  • Sense of accountability and ownership; able to work independently.
  • Integrity.

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© EuroJobsites 2020

EuroJobsites is a 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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