Director, Early Clinical Development

Company: Bristol Myers Squibb
Location: San Francisco
Posted on: January 15, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision --- transforming patients--- lives through science. In oncology, hematology, immunology and cardiovascular disease --- and one of the most diverse and promising pipelines in the industry --- each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Functional Area DescriptionThe Early Clinical Development function is part of a global scientific organization dedicated to initial evaluations of new molecules, biomarkers, and mechanistic hypotheses in humans. The group drives early clinical strategy, and the design, execution, and interpretation of studies to select the most promising drug candidates for later development.Position Summary / ObjectiveServes as a primary source of medical accountability and oversight for multiple clinical trialsManages Phase I/II studies, with demonstrated decision making capabilitiesProvides medical and scientific expertise to cross-functional BMS colleaguesMaintains matrix management responsibilities across internal and external networksPosition ResponsibilitiesMedical MonitoringServes as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept byArticulating clinical development strategyAnalyzing, interpreting, and acting on clinical trial data to support developmentServing as principal functional author for Regulatory submission, study reports, and publicationsProvides oversight and medical accountability for multiple trials across early development clinical lifecycleManages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narrativesContributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team Collaborates with Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)Fulfills GCP and compliance obligations for clinical conduct and maintains all required trainingActs as a focal point for defining and establishing relationships with key global Phase I CentersWorks on multiple trials across early development clinical lifecycleClinical Development Expertise & StrategyDesigns and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studiesLiaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical ScientistsPartners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorderKeeps up to date in the disease area by attending scientific conferences and ongoing review of the literatureKeeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscapeProvides ongoing medical education in partnership with Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and othersAd-Hoc involvement in various departmental initiatives (e.g., committees, sub-teams etc.)Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolioHealth Authority InteractionsContributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projectsAuthors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical ScientistsExternal Partnerships, Alliances, and PublicationsSits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agenciesRepresents department in business development due diligence and partner alliance management with oversightActs as a focal point for defining and establishing relationships with key global Phase 1 CentersTrack record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)Degree RequirementsAdvanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)Subspecialty fellowship training in applicable therapeutic area preferredExperience Requirements5 years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicableKey Competency RequirementsAbility to communicate and present information clearly in scientific and clinical settingsExpertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretationKnowledge of drug development processKnowledge of the components needed to execute an effective clinical plan and protocolsStrong leadership skills with proven ability to lead and work effectively in a team environmentAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.Full time

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