Clinical Oncology Director
We are seeking a Clinical Development (Oncology) Director to lead the implementation of effective Clinical Oncology strategies for our multi-national pharmaceutical company.
Responsibilities:
1. Protocol Development and Oversight: Provide scientific input during protocol development, oversee study conduct, and interpret study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
2. Clinical Study Proposal Authorship: Author the Clinical Study Proposal (CSP), prepare and present the study at Protocol Review Board (PRB), incorporate any changes suggested post-governance meetings.
3. Medical Review of Clinical Trial Data: Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review.
4. Safety Data Monitoring: Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
5. Data Package Review: Participate in blinded review of data packages intended for IDMCs.
6. Matrix Team Leadership: 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).
7. Scientific Community Engagement: Engage and influence a diverse scientific community of internal and external experts, including collaborations.
8. Study Strategy and Design: Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study.
9. Clinical Development Activities: 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.
10. Asset Knowledge: Understand the asset's biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.
11. Data Integration: Integrate data from internal, and external academic, conference and competitor sources.
12. External Expert Interactions: Interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc.
13. Business Process Implementation: 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).
14. Protocol Document Development: 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.
15. Regulatory Submissions: Drive/contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirements, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents.
16. Study Design: Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP.
17. Study Documents: 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).
18. Regulatory Reporting: 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.
19. Go/No-Go Criteria: Responsible for ensuring the Go/No-Go criteria have been set for the study.
20. Investigator Meetings: Present the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conduct.
Basic Qualifications Include:
1. Pharmaceutical Industry Experience: Experience in pharmaceutical/biotechnology industry or related clinical experience.
2. Clinical Development Experience: Experience & understanding of clinical development from early stage through to regulatory submission and market support.
3. Matrix Management: Matrix management experience.
4. Data Review/Interpretation: Experience with data review/interpretation, study design, protocol authoring, amendments.
5. IB Authorship: Experience authoring and/or collaborating on IBs, clinical study proposals, informed consent and study manuals.
6. PRF Preparation: Experience presenting or preparing PRF's – protocol review forums.
7. Leadership Skills: Excellent leadership skills.
8. Clinical Development Plan Management: Clinical development plan management experience.
Preferred Qualifications include:
1. Advanced Degree: Advanced degree (e.g. MS, PhD, PharmD).
2. Clinical Development Experience: Clinical development experience across all phases of development (I-IV).
3. Oncology Experience: Oncology or immuno-oncology experience.
4. Regulatory Requirements: Knowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory interactions/approvals.
5. Clinical Development Understanding: Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes.
6. Global Regulatory Knowledge: Thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
7. Leadership Experience: Demonstrated experience leading in both matrix and line environment to deliver projects, and manage change.
Why GSK?
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. 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.