Clinical Development Director, Respiratory, Open to flexible working
Here at GSK, we place the patient at the heart of everything we do and as leaders in respiratory disease, we are committed to improving the lives of those living with asthma, COPD and other respiratory-related illnesses.
We are constantly striving to expand knowledge and the understanding of respiratory disease to help revolutionise the way that medicines are developed. Taking an opportunistic approach, we are focused on first-in-class biologics and other emerging modalities, developing best-in-disease medicines for patients.
We're seeking a Clinical Development Director to lead phase 2A studies through to registrational programs for emerging indications in Nucala within the Respiratory Clinical Sciences group. Join our dynamic & collaborative community of clinical development physicians and scientists, as we shape and build our strategy across the respiratory organization, driving scientific innovation to deliver the next generation of transformational medicine for patients.
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 managing and contributing to 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.
- MD. Pulmonology, Critical Care, or related internal medicine background
- Deep understanding of respiratory disease and the underlying biology and potential therapeutic targets
- 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.
- Demonstrated experience using new learning and digital tools to create innovation in other areas.
- 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.
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.
- 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.
This role offers you an exceptional opportunity to develop and build your career in industry.
Closing date for applications: 28th February 2021
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, 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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