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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 influence : 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 evaluate 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 key role in the 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 guidance of disease / therapeutic area specific strategy for a drug(s) or program(s).
Manages 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
Partnering, positively interfacing, 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. 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
Responsibility for implementation of innovative methods and processes within clinical development and gains stakeholder support;
encourages others to think differently and come up with business solutions
Why you?
Basic Qualifications :
MD, PhD or PharmD degree
Extensive experience in clinical drug development with an understanding of multiple diseases, 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- 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
Preferred Qualifications :
If you have the following characteristics, it would be a plus :
Board Certification / Eligibility in Cardiovascular Disease
Significant experience in leading line and matrix teams with a strong reputation of inspiring and motivating high performance
Demonstrated track record in cardiovascular drug development, particularly heart failure
