Non-Clinical Safety Project Specialist / Toxicology Director

Waltham, MA
August 18 2021
Organization Type
Site Name: USA - Massachusetts - Waltham Posted Date: Aug 18 2021 Are you looking for a role where you will lead toxicology strategies and programs for a multi-national organization? If so, this Non-Clinical Safety Project Specialist/Toxicology Director role could be an exciting opportunity to explore. As the Non-Clinical Safety Project Specialist/Toxicology Director, you will provide scientific and regulatory vision and demonstrate leadership within project teams. You will combine your experience in toxicology and drug development with exemplary communication and interpersonal skills to communicate across all levels of GSK Research & Development (R&D). In this exciting opportunity, you will work at the forefront of toxicology and translational safety science, working in a multidisciplinary environment where you will play a key role in progressing a broad pipeline including different modalities (mAb, Cell & Gene Therapies, ASO & NCE) and a diverse range of indications driven by the GSK R&D strategy based on Immunology & Genetics. You will be accountable for timely and effective Toxicology support for projects in discovery/preclinical and clinical development and for marketed products. The incumbent is expected to demonstrate competency in interpreting toxicology data and development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance to project teams and management. This will be achieved through the integrated design of optimised translational project plans, integration of data and knowledge into quality narratives to drive internal and external decision making and regulatory interactions, documents/submissions and meetings with the overall objective of supporting the safe progression of medicines through clinical studies to patients. You will work with various business partners to drive innovative solutions and ensure the quality and performance within project teams is in accordance with regulatory guidelines & project requirements. You will be highly analytical, decisive, goal-oriented, and timeline-sensitive while maintaining the highest of scientific and ethical standards. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Provide the non-clinical safety single point accountability on integrated multi-functional project teams responsible for the development of new therapeutics from discovery to post-market. Integrate data and knowledge into concise quality project narratives to support robust, evidence based, internal and external decision making. Deliver quality nonclinical summaries and other high-level regulatory documents for internal decision bodies and external health authorities. Review reports and associated nonclinical summaries and ensure the integrity of the scientific content of regulatory documents and responses to regulatory questions. Prepare for and participate in regulatory agency interactions. Explore drug project safety risks and developing risk mitigation strategies by combining data from traditional toxicological methods with data from cutting edge in silico/in vitro model systems to build mechanistic understanding. Act as an internal consultant on non-clinical safety and on-target and off-target engagement/modulation. Contribute to the training and mentoring of other project team members. Provide scientific/technical due diligence support for Business Development activities and participate on due diligence teams in the integrated scientific/technical evaluation of external opportunities. Support the delivery of the group and departmental strategy and objectives Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in toxicology, pharmacology or related field. At least 10 years of experience as a nonclinical toxicologist and/or safety representative on project teams with experience developing both biologics and small molecules. Experience advising on toxicological strategies and experience contextualizing data for both non-clinical and clinical situations. Project leadership experience required to lead the non-clinical safety assessment contribution to projects and experience collaborating and operating effectively in a matrixed project environment. Preferred Qualifications: If you have the following characteristics, it would be a plus: MS, PhD or DABT certification Track record of influence with external consortia or regulators (FDA/EMA etc.) through concise written documentation (or oral communication). Demonstrated ability to effectively engage with a wide variety of internal/external technical and business experts, to challenge conventional thinking and implement creative ideas balanced with a high regard and understanding of GSKs Values and Expectations. Highly motivated, with strong interpersonal, organizational and communication skills with the ability to work effectively across boundaries in a dynamic and collaborative environment. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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