UK Medical Director – CSL Vifor – GMC Registered Physician

Lieu: UK - Staines/London

Votre profil

CSL Vifor is a world leader in Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. We are looking to appoint a UK and Ireland Medical Director to provide leadership to an established group of medical, quality, regulatory and safety professionals.

You will have a strong and well-established track record of success in leading a full scope of medical activities for a UK and (ideally Ireland) local operating company. Sitting on the UK Senior Leadership Team and leading both office and field based medical operations. You will have management responsibility for local medical information/pharmacvigilance and safety, GxP and oversight of regulatory activities and UK Investigator Initiated Studies..

Critical to the success of this role is working in close partnership with the UK and Ireland commercial organisations to ensure both the development of in market brands and the effective launch of pipeline products in a compliant manner, promoting collaborative solutions in partnership with commercial counterparts. 

As we continue to innovate and grow this is an exceptional opportunity to work in a business which has a track record of bringing life improving medicines to market.

Key Measures of Success

  • Demonstrated an aligned collaboration within senior leadership team and cross-functional stakeholders to meet corporate goals
  • Respected member of the country leadership team
  • Respected and consulted by global and medical teams from other countries for local medical expertise
  • Medical plan implemented to meet medical goals aligned with cross functional objectives
  • Delivered effective medical internal and external engagement initiatives
  • Execution of local data generation activities and reliable support for global activities and Investigator-Initiated Studies (IIS)
  • Demonstrated effectiveness of the field medical team measured by appropriate metrics that are defined by Global Field Medical Excellence in alignment with Country Medical Director and/ or Head FIELD MEDICAL ADVISERS
  • Compliance with local laws, regulations & codes, and CSL Vifor processes

Main Accountabilities

  • Leads Medical team to accomplish their objectives in a compliant manner and following company values and strategies
  • Strong member of the country leadership team, shaping the development of the local strategy via therapeutic area clinical knowledge and insight from HCP interactions
  • Ownership of local medical governance and is ultimate decision maker for local Medical department, incl. escalated issues
  • Development and compliant implementation of the annual country medical plan, ensuring alignment with the cross functional brand and country strategic imperatives as well as Global medical plans
  • Closely collaborate with colleagues in the development and implementation of the local brand strategy
  • Establish effective clinical engagement with medical / scientific associations, external medical experts, and other external stakeholders (e.g. patient advocacy groups, payer organizations)
  • Oversees the local data gap analysis and local data generation plan
  • Oversees the local data generation  activities and research grants
  • Management of country Medical budget
  • Compliance of Medical deliverables with local laws, regulations & codes, and company processes
  • Compliance of local Medical processes with internal global processes and guidance
  • Approval of local materials and activities
  • Registered signatory for country promotional and medical materials
  • Responsible Local Function per local ABAC guidelines
  • Medical team is adequately trained and required trainings are in place
  • Ultimate decision maker for Compliance
  • All drug safety requirements met
  • (Deputy) Local QPPV/ Local Drug Safety Responsible

Qualifications and Requirements

Minimum Requirements

  • Medical Doctor / Physician with full GMC registration.
  • Well established expertise in the ABPI (must be an existing ABPI final signatory)
  • Minimum of 7 years’ experience with pharma industry in Medical Affairs including at UK / Ireland affiliate level
  • Proven experience in people management in Medical Affairs
  • Experience with local health care compliance topics
  • Proven relationship building skills with internal and external stakeholders
  • Working knowledge of commercialization and business practices, as well as budgeting experience
  • Working knowledge in Regulatory Affairs, Pharmacovigilance and Quality Management

Preferred Requirements

  • Medical specialisation and/ or clinical / research experience in Internal Medicine, Nephrology or Cardiology
  • Significant experience with pharma industry in Medical Affairs, Clinical Development and/ or Drug Safety/ Regulatory Affairs at affiliate level and regional or global headquarters
  • Experience with non-interventional study management and conduct
  • Publication track record

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