Site Name: UK - Hertfordshire - Stevenage, GSK HQ, Upper Providence, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53, Zug House Posted Date: Dec 4 2024 Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you! As Clinical Development (Oncology) Director, you will be responsible for leading GSK medium and long-term oncology development strategies for GSK’s oncology pipeline. You will work closely with the Global Oncology Research and Development and Medical Affairs to ensure that the oncology clinical team have the highest quality capabilities and expertise. You will also ensure the optimal launch of new products and appropriate optimal patient use of currently available GSK Medicines through leadership and collaboration. Responsibilities: • Provide scientific input during protocol development, oversight of study conduct, and interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population. • Author the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Board (PRB), incorporates any changes suggested post-governance meetings • Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. • Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies. • Participate in blinded review of data packages intended for IDMCs • Lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfil regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead (PPL) and other Study Team members/stakeholders, as appropriate). • Engage and influence a diverse scientific community of internal and external experts, including collaborations. • Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study • Lead and contribute to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions. • Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature • Integrate data from internal, and external academic, conference and competitor sources • Interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc. • Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study/Clinical Development plan (CDP) • Ensure the high quality of protocol documents are developed aligned to the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe • Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents • Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP • Provide input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM) • Contribute to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.) and ensure prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc. • Responsible for ensuring the Go/No-Go criteria have been set for the study • Presents the scientific rationale and study design at Investigator Meetings and responds to • Scientific questions arising from sites during study conduct Basic Qualifications Include: • Experience in pharmaceutical/biotechnology industry or related clinical experience • Experience & understanding of clinical development from early stage through to regulatory submission and market support. • Matrix management experience • Experience with data review/interpretation, study design, protocol authoring, amendments • Experience authoring and/or collaborating on IBs, clinical study proposals, informed consent and study manuals • Experience presenting or preparing PRF’s – protocol review forums • Excellent leadership skills • Clinical development plan management experience Preferred Qualifications include: • Advanced degree (e.g. MS, PhD, PharmD) • Clinical development experience across all phases of development (I-IV). • Oncology or immuno-oncology experience • Knowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory • Interactions/approvals and active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetings Job Description: Director, Clinical Scientist Feb 2023 • Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes. • Thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support. • Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change *LI-GSK Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.