Clinical Sciences Program Lead - B7-H3

Are you energized by a highly visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the Clinical Sciences Program Lead role could be an exciting opportunity to explore.

The Clinical Sciences Program Lead is responsible for defining and driving clinical development activities for complex programs which have the potential to significantly impact our business. This role will be required to work closely with a matrix team and senior stakeholders to actively shape the evolving clinical development environment and enable GSK to deliver transformational medicine to patients in a science driven manner.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide clinical science leadership, input, and oversight of multiple clinical studies either on a late-stage asset or across multiple early phase clinical programs.
• Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.
• Provide input on clinical development plans for Early Development or Medicine Development Teams.
• Line manage or mentor other clinical development scientists.
• Ensure high quality protocol development aligned with 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.
• Lead or contribute, as appropriate, 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.
• Summarize and provide 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.
• Partnering with the Physician Project Lead to ensure patient safety during the study lifecycle, and ensuring that study objectives fulfill regulatory and reporting requirements, and support medical governance (through the Medical Monitor/Physician Project Lead and other Study Team members/stakeholders, as appropriate).
• Integrate data from internal, and external academic, conference and competitor sources.
• Understand and support creation and support of competitor landscape, medical need, regulatory strategy.
• Appropriately 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).
• 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.
• Provide direct reports with ongoing coaching, development and leadership; includes holding regular staff meetings, check-ins and 1:1 meetings

Accountabilities:

• Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP.
• Understands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virology.
• Authors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings.
• Ensures study protocol reflects input from internal and/or external experts/thought leaders.
• Liaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation / reimbursement where possible.
• Provides 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).
• Contributes to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.).
• Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.
• If Internal Safety Review Committee (ISRC)/IDMC data review is required, participates in, or leads identification of internal or external ISRC/IDMC members, respectively and preparation of charter. Co-ordinates with Medical Monitor/PPL and other Study Team members and stakeholders.
• Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objectives (through Medical Monitor/PPL and other stakeholders, as appropriate).
• Participates in eCRF development and may participate in UAT.
• Reviews the reporting and analysis plan (RAP) and advises on required outputs.
• Participates in data review ongoing through study including interim analyses, in-stream data review, 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.
• Ensures prompt, quality communications with sites regarding protocol clarification and procedural queries.
• Ensures completion of medical governance (through a physician on the team) and regulatory reporting at the start to ensure overall safety of the study subjects.
• Interpretation of study data and scientific content of clinical study reports (CSRs) and regulatory submissions.
• Ensures CSR and other documents reflect input from internal and/or external experts/thought leaders as appropriate.
• Understands and anticipates questions from internal and/or external stakeholders regarding data results.
• Working with the PPL and other stakeholders, clearly communicates results to internal and external stakeholders and regulators.
• Drives content of other clinical documents (e.g. Investigator Brochure); regulatory documents input (e.g. DSURs, BRMP, DCSI, Annual Safety Reports, PBRs, etc.).
• 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.
• Leads completion/filing of key components of clinical modules (NDA/BLA/MAA, AdCom prep, Scientific Advice) for marketing authorization.
• Prepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publications.
• Inputs into the organisation of Advisory boards and other scientific engagement activities.
• Delivers of end-of-study reports and publication/presentation of results.
• Reviews/evaluates external collaborations (e.g. SCS, ISS).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Basic life science degree with pharmaceutical industry or relevant clinical experience
• Oncology clinical development Director level leadership experience across a late-stage asset or several early-stage programs/studies

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced degree (e.g. MS, PhD, PharmD)
• Experience in antibody drug conjugates
• Demonstrated leadership, mentorship, and influencing skills in a matrixed environment
• Experience taking strong cross functional leadership role in clinical development; experience & understanding of clinical development from early stage through to regulatory submission and market support
• Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes
• Understands the study, project, and program level and can function successfully across a variety of projects
• Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery
• Demonstrates a 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
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution
• Broad understanding of the pharmaceutical industry and the clinical development process
• Clinical training and/or applicable clinical research experience; understanding of running clinical trial from concept study idea to publication
• Matrix management experience; ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
• Highly developed communication and interpersonal skills appropriate to the target audience and senior stakeholders, promoting effective decision-making where necessary

*LI-GSK

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.

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. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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

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