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. This role will lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfill regulatory and reporting requirements, and support medical governance. The role is also responsible for designing and executing clinical trials in collaboration with the Medical Director, effectively engaging and influencing a diverse scientific community of internal and external experts.

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 Informed Consent Forms (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.
• Oncology or immuno-oncology experience preferred.
• Ability to establish and build internal and external relationships at all levels.
• Good communication skills appropriate to the target audience.
• Good knowledge of disease-specific research priorities 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.

Responsibilities

• Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study.
• Lead or contribute to the end to end delivery of clinical development activities ensuring consistency with the clinical development strategy for regulatory approvals.
• 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.
• Support creation and support of competitor landscape, medical need, regulatory strategy.
• Interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, etc.
• Implement new business processes and strategies, proactively identify issues and propose strategies to manage implications and risks on clinical study.
• Ensure high quality of protocol documents are developed aligned to the Clinical Development Plan (CDP).
• Drive/contribute to documents for regulatory submissions.
• Develop studies in accordance with current GSK policies and procedures.
• Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP.
• Author the Clinical Study Proposal (CSP), prepare and present the study at Protocol Review Forum (PRF).
• Ensure study protocol reflects input from internal and/or external experts/thought leaders.
• Liaise with all functions to ensure study evaluates key aspects of the Asset Product Profile.
• Provide input into and review other relevant study documents including informed consent and protocol deviation management plan.
• Contribute to all regulatory reporting requirements.
• Ensure prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC).
• Participate in eCRF development and may participate in User Acceptance Testing (UAT).
• Review the reporting and analysis plan (RAP) and advise on required outputs.
• Participate in data review ongoing through study including interim analyses.
• Responsible for ensuring the Go/No-Go criteria have been set for the study.
• Present the scientific rationale and study design at Investigator Meetings.
• Ensure prompt, quality communications with sites regarding protocol clarification.
• Ensure completion of medical governance and regulatory reporting at the start.
• Interpret study data and scientific content of clinical study reports (CSRs) and regulatory submissions.
• Prepare and present data externally in the form of abstracts, posters, presentations for symposia and conferences.

Benefits

• Comprehensive benefits program including health insurance, retirement plans, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees