Sr. Clinical Development Director - Hepatology
Site Name: UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Feb 15 2020
As the Sr. Clinical Development Director - Hepatology, you will be the Clinical Development Lead for phase 2/3 program in Primary Biliary Cholangitis. You will lead the clinical program and integrate pivotal studies for pruritus associated with PBC as well as asset life cycle management plans.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- 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 timeframe
- 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
- Serves as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
- Lead and positively interface with and influences 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
- Integrates 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
- Assesses and predicts when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
- Anticipates problems and proactively seeks 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:
- Bachelor's degree in a science related field
- Extensive experience in GI & Hepatology 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
- Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
- Proven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans
- 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 using new learning and digital tools to create innovation in other areas
- Expertise 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:
- MD, PhD or PharmD degree valuable but not required
- Significant years of experience leading line and 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, 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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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, 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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