Preclinical Project Manager (Neurology & Ophthalmology)

Preclinical Project Manager (Neurology & Ophthalmology) - Permanent - Fully remote within US

Proclinical are seeking a Preclinical Project Manager (Neurology & Ophthalmology) to join an innovative global biopharmaceutical company in their US R&D organization.

Primary Responsibilities:

This role will be responsible for driving the progression of groundbreaking treatments from the discovery to clinical and translational stages, with a focus on mRNA, LNP and epigenetic reprograming technologies.

Preclinical Project Manager's responsibilities will be:

• Program Leadership: Take ownership of assigned biopharmaceutical programs, from initiation through completion.
• Scientific Acumen: Strong scientific foundation with ability to critically analyze and apply evolving scientific information to program design.
• Cross-Functional Collaboration: Work closely with team members across different functions, including research, development, operations, regulatory affairs, and quality assurance, to ensure seamless coordination of efforts.
• Project Management: Develop and maintain project plans, timelines, and budgets, while ensuring that projects adhere to the established goals and objectives.
• Risk Assessment and Mitigation: Identify potential risks and issues and proactively implement mitigation plans to keep projects on track.
• Urgent Issue Resolution: Respond quickly and effectively to unexpected challenges or urgent issues that may arise during the course of program development.
• Best Practice Development: Continuously evaluate and enhance project management processes, ensuring that they align with industry standards and internal quality standards.
• Communication: Serve as main point of contact for internal and external stakeholders for assigned programs.
• Resource Allocation: Work with department leads to allocate resources effectively, optimizing the utilization of talent and equipment.
• Regulatory Compliance: Ensure that programs adhere to all relevant regulatory guidelines and standards, assisting in the preparation and submission of regulatory documents as necessary.
• Documentation: Maintain comprehensive program documentation, including project plans, reports, and performance metrics.

Skills & Requirements:

• MS/PharmD/PhD in Chemistry, Biology, Biochemistry, business or another related healthcare area
• Experience within preclinical stage ophthalmic, otic, and/or neurology programs
• Proven industry work experience is desired
• Experience with non-viral LNP delivered therapeutics is desired
• Sound knowledge of drug development and understanding of FDA and ICH GCP guidelines
• Ability to collaborate across functional areas and geographic boundaries
• Experience in design and management IND enabling and translational studies
• Proficiency with Microsoft Word, Excel, PowerPoint, Project (or related tools) and capable of maintaining appropriate project documentation
• Agile mindset to adapt to evolving needs internally as well as externally
• Flexible working in a dynamic global environment

If you are having difficulty in applying or if you have any questions, please contact Max Robinsonon m.robinson@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.

INDSCIC