Clinical Development Director - IBD
Site Name: UK - London - Brentford, USA - Pennsylvania - Upper Providence
Posted Date: Nov 21 2019
Clinical Development Director and Medical Monitor - IBD sought for phase 2ab program in Inflammatory Bowel Diseases (Crohns). The Clinical Development Director will support CDL and clinical team to execute ongoing studies in Crohns, plan for potential new indications (Systemic Sclerosis, UC, other), and develop future P3 clinical program as well as overall life cycle management plans.
This role will provide you the opportunity to lead key activities to progress your career.
Job purpose and key responsibilities:
- Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
- Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP
- Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
- Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
- Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
- Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
- Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members
- Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area
- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
- Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs
- Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile.
- Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
- Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
- Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery
We are looking for professionals with these required skills to achieve our goals:
- MD degree required
- Significant experience in IBD clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
- Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
- Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
- Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
- Demonstrated experience using new learning and digital tools to create innovation in other areas
- Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
- Demonstrated experience integrating genetic data to inform and guide clinical protocols
- Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions
If you have the following characteristics, it would be a plus:
- Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance
Our values and expectationsare 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.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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