Sr. Director - Infectious Diseases Clinical Development Methods Expert (Submissions)
Site Name: UK - London - Brentford, USA - California - San Francisco, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Feb 15 2020
Sr. Director - Infectious Diseases Clinical Development Methods Expert (Submissions) sought for emerging indications and assets. CLICK HERE TO LISTEN TO A MESSAGE FROM THE MANAGER:
As a Methods Expert you will be responsible for supporting the clinical development strategy for an emerging pipeline of antibacterials, along with pivotal studies for the antibacterial portfolio. You will provide deep expertise in Infectious Disease late stage and clinical NDA and global filing preparation, while being responsible for leading a team of clinical scientists to strategically construct submission dossier and work to innovate in planning to expedite timelines and drive higher quality clinical sections of submissions. You will embed directly into late stage teams while also serving as a key internal expert for emerging programs earlier in phase around registrational considerations in your disease area. The successful candidate will be well versed in emerging trends and opportunities in your disease area and regulatory impact.
This role will provide you the opportunity to lead key activities to progress your career.
Job Purpose and Key Responsibilities:
- Accountability for education of the Clinical Sciences community to changing regulatory opportunities and clinical trial/evidence for filing in disease area
- PRF participation for all phase 3 protocol reviews from a filing perspective
- Responsible for maintaining an external focus for innovation in submission strategies
- 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
- Employing 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.
- Having accountability for risk/benefit of an asset. Actively leading and making decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals.
- Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
- Leading 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
- Delivering value and accessing insights to inform medical strategy, expand market access and to address unmet patient need
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in a science related field
- Deep knowledge in submission including regulatory changes and environment globally, clinical innovation in approval, key risks from clinical efficacy and safety perspective within infectious disease
- 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
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:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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