Associate Director, Clinical Scientist Oncology

GSK

82d

About The Position

The Associate Director, Clinical Scientist, Oncology 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 Associate Director, Clinical Scientist, Oncology 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 role 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.

Requirements

• Bachelor’s degree in Life Science or equivalent.
• 2 or more years work experience in Pharma industry or relevant clinical trial experience.
• 1 or more years Clinical trial and clinical research experience; running clinical trials in either the early or late phases.
• Experience working in a matrix management and large cross functional team environment.
• Experience generating clinical Protocols and ICFs.
• Experience working with data management and data cleaning of clinical data.

Nice To Haves

• Advanced degree (e.g. MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience (e.g. Study Coordinator at the site level).
• Oncology or immuno-oncology experience preferred.
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
• 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.
• 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.
• Good interpersonal skills.
• Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change.

Responsibilities

• 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.
• 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, etc.
• Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical study.
• 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 documents for regulatory submissions.
• Develop studies in accordance with current GSK policies and procedures.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees