Clinical Development Associate Director/Lead Clinical Scientist Oncology

Site Name: USA - Pennsylvania

• Upper Providence, UK - Hertfordshire

• Stevenage

Posted Date: Mar 14 2024

The Clinical Development (Associate) Director / (Lead) Clinical Scientist has accountability for providing clinical 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.

The Clinical Development (Associate) Director / (Lead) Clinical Scientist will 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 Director and/or the Clinical Development Lead; and other Study Team members/stakeholders, as appropriate). The Clinical Scientist is also responsible for designing and executing, in collaboration with the Medical Director, the clinical trial(s) assigned to the project. This role will effectively engage and influence a diverse scientific community of internal and external experts, including collaborations. Further to study/project accountability, the Clinical Scientist may manage other staff within Clinical Sciences.

Job Responsibilities:

The Clinical Development (Associate) Director responsibility includes, but is not limited to:

• Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study

• 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.

• 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

• 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)

• 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

• Develop studies in accordance with current GSK policies and procedures

• As appropriate, Lead Clinical Matrix Teams

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 Bachelor's degree or equivalent.

• Three or more years of industry or relevant clinical experience.

• Three or more years of Oncology or immuno-oncology experience preferred

Preferred Qualifications:

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

• Advanced degree (e.g. MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience (e.g. Study Coordinator at the site level)

• Good communication skills appropriate to the target audience, promoting effective decision-making where necessary

• Good knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

• 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

• Broad understanding of the pharmaceutical industry and the clinical development process

• Good leadership and influencing skills

• 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.

• 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.

• Good interpersonal skills

• 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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