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Associate Preclinical
3 months ago
Associate Preclinical & Translational Project Leader - Permanent - Fully remote within US
Proclinical are seeking an Associate Program Lead (APL) to join an innovative global biopharmaceutical company.
Primary Responsibilities:
This role will be responsible for driving the progression of groundbreaking treatments from the discovery to clinical and translational stages.
Skills & Requirements:
MS/PharmD/PhD in Chemistry, Biology, Biochemistry, business or another related healthcare areaExperience within preclinical stage ophthalmic, otic, and/or neurology programsProven industry work experience is desiredSound knowledge of drug development and understanding of FDA and ICH GCP guidelinesAbility to collaborate across functional areas and geographic boundariesExperience in design and management IND enabling and translational studiesProficiency with Microsoft Word, Excel, PowerPoint, Project (or related tools) and capable of maintaining appropriate project documentationAgile mindset to adapt to evolving needs internally as well as externallyFlexible working in a dynamic global environment The Associate Preclinical & Translational Project Leader'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.If you are having difficulty in applying or if you have any questions, please contact Max Robinson on m
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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