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Job type: Permanent

Discipline: Pharmacology

Location: United States

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 Robinson on 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