Sr. Clinical Development Director - Lupus/Rheumatology
- Waltham, MA
Site Name: UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Feb 15 2020
Clinical leader sought for new Benlysta indications and potential emerging indications from the ongoing late stage rheumatology portfolio. As Sr. Clinical Development Director, you will be responsible for working across the matrix to lead studies from the scientific perspective and be a key contributor to clinical submission activities.
This role will provide you the opportunity to lead key activities to progress your career.
Job Purpose and Key Responsibilities:
- Providing integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
- Strategic Leadership: 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 time frame
- Establishing expeditious clinical development timelines, incorporating 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 coaching and mentoring and potential direct line management
Scientific Leadership, Direction and Strategy:
- Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compounds
- Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
- Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
- Integrating 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 risk/benefit of the asset. Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriate
- Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
- Anticipating problems and proactively seeking input from other teams' members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems
- Accountable for the evaluation of clinical study/program probability of technical success (PTS)
Study & Program Design and Evidence Generation
- Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management
- Leads 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
- Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need
Creating Innovative Scientific and Technical Solutions:
- Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology
- 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:
- A physician (M.D. or equivalent)
- At least 2+ years of clinical development
- Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
If you have the following characteristics, it would be a plus:
- Board Certification/Qualification, in selected therapeutic area
- Familiarity with the key medical/scientific experts within the therapeutic field, with the capability of effectively interacting and/or collaborating with the experts
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, 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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