VP Clinical Development
Proclinical is currently for a VP of Therapeutic Area Head Lysosomal Storage Diseases with a clinical-stage gene therapy company located in Boston, MA. As the Therapeutic Area Head Lysosomal Storage Diseases VP, you will be responsible for the design and strategy of our clinical stage LSD programs and make sure the clinical development plan is well aligned with the broader program strategy and assist medical affairs in the development of a scientific platform for the LSD indications we pursue.
- Manages clinical programs within LSD therapeutic area to ensure strategic planning and delivery of the CDP (and associated goals) to the organization
- Act 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. This person will also be responsible for the LSD clinical development budget forecast
- S/he will be 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. They (or their delegate) will also serve as clinical representative at all FDA meetings
- Organize and prepare for Advisory Board meetings
- Utilize novel and creative methods to resolve clinical development problems
- Ensure compliance across clinical development with all company 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
Skills and Requirements:
- MD or the International equivalent
- Minimum of 10 years Pharmaceutical/Biotech industry experience including international clinical development programs. Preference for someone with strong gene therapy and/or Rare Disease experience
- Ability to work collaboratively in a team matrix environment
- Significant knowledge and experience in the design and execution of clinical trials, including all phases of clinical research
- Ability to work independently to resolve challenges and conflicts
- Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
If you are having difficulty in applying or if you have any questions, please contact Ella Jobson at (+1) 646-868-5142 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.