Director Of Translational Science

Proclinical is currently recruiting for a Director of Translational Science for a biotechnology company located in Boston, MA. Successful candidate will lead the scientific development for the AAV-based platform, and additional programs. The role requires breadth of experience across viral therapy non-clinical development, ocular biology, team building & development, laboratory and CRO management, intellectual property, and KOL and strategic partnering.

Job Responsibilities:

• Work collaboratively with senior management, scientific founders, clinical and other external advisors, IP counsel, and others to maximize the potential the company to meet patient needs.
• Build, develop and grow scientific team and facilities to support VDRE-001 and additional non-clinical development programs.
• Work with others to develop study plans and timelines; mentor team to ensure all projects are appropriately prioritized and key goals are met on time.
• Assist due diligence efforts, audits, monitors, landscape analyses, and site visits.
• Write, review and/or finalize study reports, SOPs, and appropriate sections of regulatory filings.
• Work effectively within the non-clinical development team, to achieve corporate and program goals; collaborate and build strong internal network to leverage technical leadership.
• Efficiently communicate project status and risks; present data and strategies adequately to internal and external stakeholders, including investors and regulatory agencies.
• Employ problem-solving and intellectual curiosity in all scientific endeavors; drive the incorporation of knowledge of current regulations, guidance and competitive environment into decisions and strategy.

Skills and Requirements:

• A PhD in pertinent life sciences or equivalent is required.
• 8+ years relevant industry experience, with biotechnology and/or pharmaceutical companies.
• Proven track record as a key member of a team that led and implemented the non-clinical enablement of one or more INDs is required.
• Direct experience drafting the non-clinical sections of successful IND submissions is required; direct experience interacting with FDA and/or European regulators strongly preferred.
• Experience and direct responsibility with AAV viral vectors required; and ocular AAV-based experience is strongly preferred.
• Extensive experience with animal models used in retina biology research and development.
• Understands Good Laboratory Practices; proficient in use of ELN and safety/quality systems.
• Ability to work in interdisciplinary teams and with all levels of the company.
• Excellent presentation and writing skills are required.
• Experience in a cross-functional team, where interactions with other, equally talented individuals requires technical expertise, negotiating skills and diplomacy.
• Excellent understanding of both scientific and regulatory requirements related to pharmaceutical gene therapy development, manufacturing and specifications.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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