(Sr.) Clinical Development Director - Rheumatology/Immunology
- Collegeville, PA
Site Name: Belgium-Wavre, UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, Warsaw, USA - Pennsylvania - Upper Providence
Posted Date: May 5 2021
(Senior) Clinical Development Director - Rheumatology sought to provide clinical and scientific support for existing , new, and potential emerging indications in the Rheumatology portfolio. The Clinical Development Director will work with the Early Development Team to implement efficient collaboration between Research and Development and to define clinical development programs.
This role will provide you the opportunity to lead key activities to progress your career.
Job purpose and key responsibilities:
- Leading/supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
- Strategic Leadership/alignment: Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the 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
- Establishing/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 and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
- Playing an active role in the technical and leadership development of Clinical Sciences staff via mentoring and coaching and potential direct line management.
- 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.
- Leading and positively 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
- Integrating/gathering inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile.
- Accountable for/contributing to the evaluation of clinical study/program probability of technical success (PTS).
- Actively leads and makes decisions which balance risk/benefit at the study and/or project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate.
- Drives/contributes to the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management.
- Leads/significantly contributes to clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
- Provides effective leadership support / oversight of evidence generation activities to assure patient safety and study delivery.
- Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in a medical science related field
- Experience in Immunology/Rheumatology clinical drug development
- Clinical training and/or applicable clinical research experience; experience with clinical development planning for an asset and/or indication and delivering clinical program from concept to filing.
- Experience managing complex projects and working collaboratively with multiple stakeholders
- Experience maximizing and integrating genetic data to advance disease understanding and inform and guide clinical development plans
- Experience with clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
- E xperience with digital tools intended to create innovation
- E xperience integrating genetic data to inform and guide clinical protocols
- Experience in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content
If you have the following characteristics, it would be a plus:
- M D, PhD or PharmD degree valuable but not required
- Thorough understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
- Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements in responsible area
- Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)
- 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
- Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance
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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