Site Name: USA - Pennsylvania - Upper Providence, Cambridge MA, UK - Hertfordshire - Stevenage Posted Date: Nov 22 2024 Do you have experience in Biologics&Oligonucleotide therapeutics Drug Development? Are you interested in expanding your role? The GSK global Nonclinical Safety (Toxicology) Project Specialist organization is looking for a Project Specialist (Director) to join our team, based in either Philadelphia/Boston, USA, or Stevenage, UK. In this role, the individual will serve as a project toxicologist supporting a diverse and exciting portfolio in an industry leading global pharmaceutical company with 100 years of discovering and developing transformative medicines and vaccines. The candidate must have an in-depth knowledge&experience of complex biologics and/or oligonucleotide therapeutics drug development. In addition, the candidate should have significant experience in the authoring of a broad range of regulatory documentation reflective of experience of drug development associated with drug discovery through to registration&post-marketing activities. Working collaboratively with key matrix project team members (i.e. Project Leaders, DMPK, Clinical Pharmacology, Clinical (Safety, Development),&Regulatory, etc.), across different therapeutic areas, you will be responsible for designing and delivering the nonclinical safety strategy to inform key project and portfolio decisions from lead optimization through regulatory filing to post-marketing activities, impacting the drug label, successful medicine launch and continued access to medicines for patients. KEY RESPONSIBILITIES Provide nonclinical safety input into project strategy and nonclinical safety data interpretation primarily for Biologics and/or Oligonucleotide therapeutic projects. Efficiently manage your time and project requests and be accountable for nonclinical safety deliverables to ensure effective support of your projects. Influence Project Teams and Research Units from both strategy and scientific perspective. A track record in support of multiple projects across different therapeutic areas which may include portfolio responsibilities. Ensure that differentiated development options are available to influence&support the clinical development plan and strategy. Implement best practices and share insight across the Nonclinical Safety (Toxicology) Project Specialist team to help drive and embed strategic direction. Develop and maintain excellent working relations with key matrix partners ensuring strategic alignment and optimal collaboration and communication. Responsible for coordinating and delivering high-quality nonclinical safety contributions to regulatory documents and regulatory questions for the projects you support. Actively support cross Nonclinical Safety initiatives as a representative from the Project Specialists team to drive outstanding, future looking science and operations within GSK. Leader/coach/mentor of other project representatives expressing interest in developing drug development skills and experience. Sustained record of highly effective collaboration, flexible and courageous thinking at team, department, project and/or portfolio level (or equivalent), leading matrix teams of cross-discipline scientists and coordinating key outputs to drive substantial change within GSK. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MSc or BSc Degree with 10 years in a field relevant to Nonclinical Safety (Toxicology). PhD with 7 years in a field relevant to Nonclinical Safety (Toxicology). Preferred Qualifications/Experience: If you have the following characteristics, it would be a plus: DABT or equivalent. Excellent communication skills, strategic thinker, demonstrated learning agility, and ability to pivot between scientific and strategic issues. Demonstrated ability of developing and maintaining strong working relationships and supporting high-performing teams from multiple disciplines. Demonstrated digital fluency including application of Generative AI. Experience, understanding and proven track record in the preparation of regulatory documentation and interactions with regulatory agencies. Ability to manage project resources and budgets. J-18808-Ljbffr