VP (Therapeutic Area Head Lysosomal Storage Diseases)

Hobson Prior currently have an exciting opportunity for a VP Therapeutic Area Head Lysosomal Storage Diseases (LSDs) to join a top biotechnology organisation on a permanent basis in the US. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.

Job Responsibilities:

• You will manage clinical programs within LSD therapeutic area to ensure strategic planning and delivery of the CDP (and associated goals) to the organisation.
• Represent as the US/international clinical lead for the compound to both internally and externally facing stakeholders (ex, CRO, KOL, Clinical site staff).
• Oversee development of study protocols, the conduct of studies and the analyses of data for all clinical programs.
• You will be the subject matter expert on all LSD-related clinical and medical strategic initiatives.
• Lead clinical sections of regulatory documents (IND, MAA/NDA) and in the responses to inquiries.
• Prepare for meetings with FDA and healthcare authorities. Assist Regulatory Strategy staff in the creation of the filing strategy.
• Organise and prepare for Advisory Board meetings.
• Utilize novel and creative methods to resolve clinical development problems.
• Ensure compliance across clinical development with all the organisation's SOPs, ICH, GCP and other national and international regulatory requirements.
• May provide strategic input in the evaluation and planning for external business opportunities (e.g. diligence reviews).
• Contribute to progression of pipeline.
• Serve as an exemplary leader; Mentor, Train, and develop staff as needed.
• Actively contribute to creating and embedding a culture of excellence.

Key Skills:

• Ability to work collaboratively in a team matrix environment.
• Ability to work independently to resolve challenges and conflicts.
• Excellent communication skills and strong leadership skills.

Requirements:

• MD or the International equivalent.
• A minimum of 10 years Pharmaceutical/Biotech industry experience including international clinical development programs.
• Strong gene therapy and/or Rare Disease experience would preferred.
• Substantial knowledge and experience in the design and execution of clinical trials, including all phases of clinical research.
• Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process.
• Strong working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes.
• Experience in filing and defending US INDs and/or NDAs.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.