VP, Research & Development

Job purpose

Reporting to the President & Chief Executive Officer (CEO) and the Global Head of R&D, the Head of Research & Development (R&D) will play a lead role in delivering business critical R&D programmes. The Head of R&D is a member of the Molecular Imaging Senior Leadership Team and will have management responsibility for the following functions:
Biometrics;
Chemistry, Manufacturing & Control (CMC);
Clinical Operations;
Editorial (Medical Writing);
Imaging;
Non-Clinical; R&D Programme Management

• Biometrics (to include biostatistics, statistical programming, and data management), ensuring operational delivery and the provision of strategic advice concerning statistical methods and data management activities.
• Chemistry, Manufacturing & Control (CMC) ensuring the robust manufacturing and supply of materials used in the manufacture of investigational and finished commercial radiopharmaceutical products.
• Clinical operations, ensuring operational delivery and the provision of strategic advice concerning the design, feasibility and execution of all clinical studies.
• Editorial (medical writing), ensuring the development and implementation of strategic publication plans and the dissemination of scientific and clinical data (e.g., via manuscripts and conference presentations).
• Imaging, providing medical physics support, including radiation physics, medical imaging physics and imaging analytics expertise.
• Non-clinical, to include evaluations of non-clinical toxicology, safety and efficacy.
• R&D programme management, including:
  Delivery of the programme strategy (in accordance with the Long-Range Plan and in close collaboration with colleagues in Clinical Development, Commercial, Finance, Innovation & Strategy, Legal (incl. Intellectual Property), Medical Affairs, Pharmacovigilance & Quality and Regulatory Affairs). Operational oversight and project delivery, in compliance with applicable laws, industry codes and regulations Budget management (including Long-Range Planning, Annual Budget and Rolling Forecast 2 & 3 and related resource allocation & planning), Portfolio review, Risk management, Regular reporting to the Executive Committee and Board of Directors including progress in achieving strategic objectives;
  
  advising of any significant variance from the approved strategic plans and budget; and any significant programme issues.
• Research and Development Collaborating with the New Asset Evaluation Team, specifically on the identification and technical assessment of new licensing, lifecycle and geographic expansion opportunities.
• Collaborations with academia, pharma and imaging equipment providers.
• All matters of significant organisational structure within R&D, including development of the capabilities of the internal workforce and the recruitment, promotion, retention, succession planning & dismissal of employees, in conjunction with Human Resources.
• Establish or implement departmental policies, goals, objectives, or procedures in conjunction with the Leadership Team and Global R&D at Bracco.
• Other duties as determined by business needs.

• Educated to at least degree level, preferably with a PhD in science or life science (or equivalent research experience).
• Professional Experience, Knowledge, & Technical Skills Significant experience in clinical drug development and particularly the development of medical imaging agents and radiopharmaceuticals is key, as is significant experience of staff & performance management. A strong scientific background in a relevant area in a relevant scientific discipline an advantage and awareness of relevant guidelines and regulations governing drug development activities, particularly imaging drugs, a pre-requisite.
  
  Knowledge of Regulatory Authority (i.e., EMA, FDA) and Good Clinical Practice (GCP) guidelines.
• Proven leadership, organisational, facilitation, negotiation, collaboration, empowerment, and interpersonal skills with the ability to work effectively with others at all levels of the organisation.
• Experience with cross-functional and highly matrixed organizations.
• Ability to coach, mentor, develop and…