Director Environmental Risk Assessment Pharmaceuticals in the Environment

The purpose of this role is to provide clear direction, support, and oversight for selected EHS programs in alignment with overall company EHS strategy. Serve as the subject matter expert (SME) responsible for providing robust and timely environmental risk assessments in support of drug filings to regulatory agencies. This role provides technical leadership and strategic support across the organization on issues related to pharmaceuticals in the environment, helping the company evaluate and manage environmental risks, support sustainability initiatives, and shape science-based internal and external policies.

Key Responsibilities include, but are not limited to:

• Lead GSK global Environmental Risk Assessment operational needs in support of new drug filings.
• Provide robust and timely environmental risk assessments in support of worldwide GSK drug filings, especially EU & US.
• Design intelligent environmental fate and effects testing strategies based on the physico-chemical properties of active pharmaceutical ingredients (API) with a view to assessing their environmental impact.
• Commission & monitor Environmental fate and effects Studies outsourced to Contract Research Organisations (CROs), including drafting, reviewing and finalising study protocols and reports.
• Support GSK engagement in the Pharmaceuticals in the Environment agenda.
• Provide critical technical input & support to our Pharmaceuticals in the Environment Task Force in terms of engaging with EU stakeholders from a considered & balanced scientific point of view.
• Represent GSK perspective to stakeholders, with the objective of helping all stakeholders make the right science-based decisions that support both environmental & patient needs.
• Input into GSK strategy around key active pharmaceutical ingredients currently under scrutiny within the EU as well provide strategic input into GSK’s longer-term strategy on this topic more broadly.
• Recommend and/or lead scientific discourse or enquiry in support of GSK on this topic.
• Represent GSK as a credible external subject matter expert on Pharmaceuticals in the Environment.
• Participate in academic and scientific liaison and collaboration in support of original scientific projects that promote the science of Pharmaceuticals in the Environment (PiE).
• Lead GSK’s involvement in PREMIER, a 6-year cross industry project under the Innovative Medicines Initiative (IMI), focused on the prioritisation and risk evaluation of legacy medicines in the environment.
• Represent GSK across scientific conferences, task force groups, technical forums and workshops, including Industry and Trade Association technical activities relating to environmental risk assessment and pharmaceuticals in the environment.
• Active membership and participation of cross-industry ERA expert user’s network, Inter-Association Initiative PiE Task Force and relevant work streams to shape Industry strategy.
• Review relevant scientific literature on an ongoing basis.
• Application of environmental ecotoxicological data to underpin responsible aqueous waste disposal strategies at GSK manufacturing sites.
• Generate PNEC for all GSK and non-GSK APIs in support of GSK management of aqueous discharge from manufacturing sites.
• Provide technical support to GSK sites around site ERA including options for refinement and modelling of API biodegradation and removal via wastewater treatment.
• Where warranted and justified generate preliminary environmental fate and effects dataset to support refinement of PNEC.
• Support cross-functional teams within EHS where appropriate, including toxicology and the preparation of SDSs (safety data sheets).
• Collaborate with EHS counterparts to ensure consistency in delivering the company strategy as well as any departmental priorities.

Basic Qualifications:

• A minimum of a BSc degree within a biochemistry/chemistry or environmental science related field.
• Recognised EHS professional internally and externally.
• Proven project management and managerial skills abilities.
• The ideal candidate is likely to have originated from a technical background in a chemicals-related field but will have developed a strategic working knowledge of chemical regulations and a working knowledge of environmental hazard and risk assessment, including ERAs for medical products, REACH, EU Water Framework Directive.
• Expertise in Environmental Risk Assessment of pharmaceuticals is preferred but consideration will be given to candidates with broader ERA experience in chemicals e.g. pesticides, biocides, chemicals.
• The candidate should have awareness and understanding of key stakeholder groups surrounding these issues from Regulators to Trade Bodies.
• Awareness of development of PiE regulations elsewhere in the world such as Canada, Australia, Japan as well as the potential impact of PiE on Lower and Middle Income countries (LMIC) would be useful.
• The candidate will have sufficient educational qualifications and work experience to be considered a subject matter expert and be able to be conversant and communicate.

Preferred Qualifications:

• PHD or advanced education preferred.
• Targeted areas of expertise in Environmental Toxicology and/or Environmental Risk Assessment.
• Practical experience & understanding of the topic of Pharmaceuticals in the Environment (PiE).
• Good external networks to benchmark and to effectively represent the interests of GSK.
• Experience in pharmaceutical, chemical, or high-risk industry.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.