- Driving projects to rigorous assessments of therapeutic success (or failure) by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible by the early POC stage of development. This pivot informs future scientific, medical, and business program approaches.
- Early engagement with Drug Discovery Unit (DDU) to assist in research portfolio prioritization.
- Provide early clinical expertise and recommendations to DDU on go/no-go decisions at stage-ups.
- Creation of the early Clinical Development Plan.
- Study design and implementation of clinical protocols for first in human studies through early proof of concept/proof of mechanism.
- Ensure that critical TREC experiments deliver timely go/no-go decisions.
- Coordination with other functional experts within TREC (e.g. quantitative clinical pharmacology, imaging and biomarkers) to utilize all modalities to accelerate or enhance the decision making process
- Engagement of GI Therapeutic Area Unit (TAU) to ensure early clinical studies support decision making for late phase development.
- Ensure seamless transition between research and clinical development, driving the early plan as part of the overall Asset Strategy in the GPT.
- Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as well as co-authored publications in scientific journals.
- Ensure agile, timely management of issues arising from ongoing studies (e.g adverse events).
- Work directly with global product teams and global clinical development teams to support biomarker / imaging strategies and implementation plans across therapeutic areas.
- Support the Working Groups that support the development and execution of teams biomarker and personalized medicine strategy and implementation plan.
- Work closely with early clinical operations, quality, procurement, and contracting groups to support study team implementation of studies.
- Provide clinical expertise for early phase external opportunities and participate in due diligence teams.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD, MD/PhD preferred
- Formal clinical training, including fellowship training with GI specialization as well as translational/experimental medicine expertise preferred.
- Clinical development experience should be in academia and/or industry including early clinical trial design and implementation, documentation / filing.
- Discovery/basic research experience is preferred.
- Academic clinical experience is preferred.
- A rigorous record of scientific publication is required.
- Minimum 5-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience.
- Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development.
- Driving results is essential. Need to be able to motivate individuals to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback.
- Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision.
- Planning, priority setting, and time management are essential.
- Accountability takes responsibility for their own performance and accept full ownership of issues, problems, and opportunities, regardless of the source.
- Comfort with ambiguity is required.
- Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others' ideas.
- Excellent communication, interpersonal sensitivity, and negotiating skills
- Team-work, partnership and collaboration skills
- GI-related expertise
- Clinical science
- Translational medicine, including biomarkers
- Nonclinical and clinical drug discovery and development
- Regional/global Regulatory requirements
- Ability to drive to or fly to various meetings or client sites, including overnight trips. International travel will be required.
- Requires approximately 20 - 30% travel.
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