Japan Clinical Development Lead

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Clinical Development Lead EMPLOYEE JOB PROFILE (EJP) – JOB DESCRIPTION Job Title Japan Clinical Development Lead (JCDL), Disease area / Dev. stage head Division R&D / Global Drug Development / Japan Clinical Development Functional Area Description The Japan Clinical Development Lead (Disease area / Dev. stage head) sits within Japan Clinical Development, which is a Japan organization dedicated to the effective design and execution of drug development. Japan Clinical Development serves as the leader of the cross functional Japan Development team and drives clinical development strategy for Japan, design, execution, and interpretation of clinical trials. Position Summary / Objective JCDLs (Disease area / Dev. stage head) are matrix leaders and managers who lead, develop, motivate and achieve results through teams and subordinates; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy Serves as the clinical point of accountability for the overall Japan clinical development plan for the assigned disease area Engage and collaborates with BMS global/alliance counterpart to align with Japan strategy as a representative of BMS in assigned disease area or assets Oversight to ensure studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals to fit Japan specific requirement/situation Play JCDLs (expert) as needed The JCDL (Disease area / Dev. stage head) reports to (input relative role) May act as the direct or matrix manager to JCDLs (expert), J Clinical Trial Physicians (CTPs) and J Clinical Scientists (CS) Position Responsibilities Japan Development Leader parts Accountable for driving the execution of the Japan strategy in partnership with the Development Project Manager. Represents the assigned area to fit Japan specific requirement to enable timely and well-informed decision making at major stage gates Engages global development team, Japan senior leaders and functional area stakeholders to ensure alignment of Japan program strategy and operational plans with functional area capabilities, including adequate and timely resourcing of development teams Oversights the cross functional Japan development team activities to: Assess Japan business opportunities informed by scientific, regulatory, clinical and commercial aspects Holistically assesses data needs for Registrational and Non-Registrational Data Generation for Japan Proactively identifies potential risks and drives the execution of mitigation strategies Interpret and communicate key clinical trial results and regulatory milestones to appropriate governance boards Develop a data generation strategy that addresses both regulatory and reimbursement needs for Japan Partner with both internal and external teams to develop and execute a Publication Strategy for Japan Oversee relevant sub-teams (e.g. Japan study team) and ensures clear goals and performance standards are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables Builds and maintains collaborative relationships with external stakeholders (Opinion Leaders, Strategic Alliance Partners, Patient Advocacy Leaders, Health Authorities) Actively supports Investor Relations and Public Affairs in managing external BMS communications in Japan Clinical Development / Clinical Science parts Accountable for the clinical contribution to the development of each indication strategy in assigned area, including registrational and non-registrational studies, with the support of the CDL (expert), the CTPs and/or Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s), clinical scientist(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians and clinical scientists May serve as CDL (expert) as necessary Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in assigned area Serves as Primary Clinical Representative in Regulatory interactions May provide input into TPP plan from a Japan perspective to ensure optimal development outcomes Collaborates with other relative functions to develop asset level and/or disease area risk management plan for Japan, resolves issues with other relative functions, and raises to global DT or senior leaders as needed Sets executional priorities and partners with CDL (expert), CTP,CS and operation team to support executional delivery of studies Degree Requirements MD/PhD/PharmD preferred Experience Requirements Experience of drug development in (input relative disease area) is preferable Experience in managing/leading high performance, cross-functional teams (matrix) or complex organizations successfully in Japan Expertise in the design, analysis, publication and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes: Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development in Japan A minimum of 5 years of clinical development / industry experience preferred Experience with clinical components of regulatory submissions and clinical presentations to regulatory authorities Key Competency Requirements Extensive working knowledge in the drug development process, along with expertise in one or more of the relevant areas (e.g. clinical, regulatory, program management, project planning and management, medical) Demonstrated ability to effectively collaborate across functional boundaries (e.g. regulatory, project management, operation, PV, medical, marketing, access, etc.) and building strong external relationships Broad understanding of domestic and international issues relative to the pharmaceutical industry Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets for Japan Abreast of scientific issues as they impact business development and strategic planning for Japan CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and regulatory circumstance, and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Broad, in-depth knowledge of both clinical and medical science within assigned therapeutic area Overseeing Phase 1 – Phase 3 studies, with demonstrated decision making capabilities Fluent in spoken and written English for business Travel Required Domestic and International travel may be required. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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