Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham
Posted Date: Feb 23 2021
Would you like to utilize your Clinical Development leadership expertise supporting an exciting Oncology portfolio? If so, this could be an excellent opportunity to explore.
As Director, Clinical Development / Clinical Scientist you will be providing input on Oncology clinical and strategic issues that impact the success of our Medicine Development units.
This role can be based at our Collegeville PA, Waltham MA or Stevenage UK sites.
This role will give YOU the opportunity to work on key activities to progress YOUR career, these responsibilities include some of the following...
- Provide scientific 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.
- 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 (through the Medical Monitor/Physician Project Lead (PPL) and other Study Team members/stakeholders, as appropriate).
- E ngage and influence a diverse scientific community of internal and external experts, including collaborations.
- Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the study
- 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.
- 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
- 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
- Accountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP
- Author the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetings
- 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)
- 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.
- 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
We are looking for professionals with these required skills to achieve our goals:
- Bachelors in Life Science degree
- 5 + years of industry or relevant clinical experience
- Experience & understanding of clinical development from early stage through to regulatory submission and market support.
- Matrix management experience
- Experience with data review/interpretation, study design, protocol authoring, amendments
- Clinical development plan management experience
- Experience authoring and/or collaborating on IBs, clinical study proposals, informed consent and study manuals
- Experience presenting or preparing PRF's - protocol review forums
If you have the following characteristics, it would be a plus:
- Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
- Oncology or immuno-oncology experience
- 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
- Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes.
- 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
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, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritisation, execution, delivering performance.
- Setting strategic direction and leading on-going organisational transformation.
- Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
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