Non-Clinical Safety Project Specialist / Toxicology Director, Open to flexible working
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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Demonstrated expertise, and ongoing interest in one (or more) non-clinical safety areas, eg. General Toxicology, Genetic Toxicology, Neurotoxicology, In silico safety modelling tools etc.,
- May be a recognized leader in a specific scientific field or discipline of interest, maintaining an extensive network (with a publication record) in that specific scientific field. Is frequently consulted within and outside TPPS (and sometimes outside GSK by international organizations or bodies).
- Sufficient breadth of knowledge of all areas of non-clinical safety (and supportive processes) to strategically and efficiently drive non-clinical safety aspects of projects in discovery, development and/or post-marketing phases, including provision for external diligence activities.
- Has a good knowledge of other disciplines (e.g. Pharmacology, ADME, Clinical, etc.) to enable visible contributions to a multi-disciplinary scientific/operational strategy.
- Sustained ability to support multiple projects across various modalities, business unit (BU), and/or therapeutic areas (TAs).
- Proven competency to integrate data and craft clear and appropriate narratives for internal governance decision reviews and/or regulatory documentation (IB/IND/NDA/BLA).
- Proven excellent communicator (both written and verbal skills) which supports the capability to positively influencing external stakeholders, e.g. regulators (at a project level) or senior leaders in GSK (e.g. RU/BU heads or governance panel members).
- Coaches/mentors other PTMs and is highly regarded as a reviewer/approver of regulatory and or internal milestone documents.
- Track record of influence with external consortia or regulators (FDA/EMA/etc) through concise written documentation (or oral communication) and ability to coordinate clear and informative responses to subsequent questions or challenges, through the various phases of drug discovery and development
- Is highly regarded with proven track record as a leader/coach/mentor of other PTMs and whose broad insight is valued as a reviewer/approver of regulatory and/or internal milestone documents.
- Expectation of experience in training, mentoring and coaching others e.g. as reviewer/approver, through training courses, or via specific mentoring arrangements.
- Sustained record of highly effective teamwork leveraging SMEs as required, providing clear and regular line of sight and leadership to project issues and progression challenges.
- Sustained record of flexible and courageous thinking, providing multiple options to project teams, EDLs/MDLs, etc.
- Ability to effectively prioritise multiple and conflicting objectives.
- Clearly demonstrates political and learning agility, and readily moves between scientific and strategic issues.
- Contributes strategically to the TPPS objectives, and the wider non-clinical safety (NCS) organization and (IVIVT) department.
We are looking for professionals with these required skills to achieve our goals:
- BSc in toxicology, pharmacology or related field
- At least 10 years of experience as a nonclinical safety representative on project teams with strong foundation as a toxicologist and with experience of developing both biologics and small molecules.
- Experience advising on toxicological strategies, and demonstrated ability to contextualise data for both non-clinical and clinical situations
- Project leadership skills required to lead the non-clinical safety assessment contribution to a number of projects and with an ability to collaborate and operate effectively in a matrix project environment
If you have the following characteristics, it would be a plus:
- MS or PhD in toxicology, pharmacology or related field; DABT certification desirable but not required
- Demonstrated ability 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 matrix environment
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.
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, colour, 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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