VP Clinical Development - Hematology

Proclinical is urgently recruiting for a VP of Clinical Development, Hematology for a leading biotechnology company located in Boston, MA. The successful candidate hired will be a sophisticated leader who has the right degree of drive and independence with a very strong track record in drug development. As the Clinical Development VP, you will be responsible for the design and strategy of the client's clinical stage LSD programs and make sure the clinical development plan is well aligned with the broader program strategy.

Job Responsibilities:

• Manages clinical programs within the hemophilia 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
• 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
• Proactively identify program risks, and create and implement mitigation strategies;
• Contribute to progression of pipeline
• Remain up to date with hemophilia therapeutic area and ensure this is appropriately communicated across the organization
• Training of staff in hemophilia therapeutic area as required
• Provide medical support and direction to the project teams and other groups within company as required
• Leading and managing KOL interactions
• Ensuring medical content of documents is accurate and of high quality
• Appropriately manage and engage any third-party providers as necessary, e.g. event organizers, to ensure business objectives are met
• Presentations to advisory committees, investigators and scientific meetings
• 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)
• Actively contribute to creating and embedding a culture of excellence

Skills and Requirements:

• MD or equivalent
• Minimum of 8 years of industry experience in clinical development. Ideally from early development, through CTA/IND, to filing of MAA/BLA and post approval development
• Experience of the development of gene therapy medicinal products or rare disease products
• Experience leading or collaborating on BLA preparations and/or approvals preferred.
• Although not a prerequisite, special consideration will be given to candidates with specialty experience or training in hematology
• A demonstrated ability to create and drive an effective medical strategy.
• Substantial experience in designing and executing clinical studies.

Preferred Skills:

• Deep knowledge and understanding of hemophilia and a demonstrated ability to learn about other therapy areas
• The ability to plan, coordinate and lead activities simultaneously on multiple projects
• The ability to work in a matrix and interact effectively with all levels of seniority both internally and externally.
• Good interpersonal and leadership skills.
• The ability to drive themselves towards goals
• Strong organizational and strategic skills
• Well established negotiating and influencing skills
• Sound organizational and time management skills.
• Proven ability to meet strict deadlines; manage competing priorities and changing demands
• Confident, independent and decisive; a self-starter, proactive and results-oriented with high performance standards. Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
• "Hands-on", "roll-up-the-sleeves" leader who understands the need for involvement at all levels of activity within a small company environment. Extremely bright with a highly strategic nature but also balanced with a biotech mindset and an attitude that gets things done.

Additional Skills:

• Excellent communication skills
• Excellent presentation skills

If you are having difficulty in applying or if you have any questions, please contact Ella Jobson at (+1) 646-868-5142 or e.jobson@proclinical.com.

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.

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