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Senior Director, Early Clinical Development (MD) - Neuroscience

Company: Disability Solutions
Location: Cambridge
Posted on: July 1, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: careers.bms.com/working-with-us .The Senior Director will be the clinical lead to progress multiple early clinical assets from first-in-human through proof-of-concept and will prepare the clinical development plan, design clinical trials and lead the clinical development teams. Extensive experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is a requirement. Demonstrated expertise in basic research related to neurodegeneration and/or neuropsychiatry is a plus.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 / Objective

  • Serve as the clinical point of accountability for the Development Team and responsible for the overall clinical development plan for asset(s) in one or more indication(s)
  • Demonstrate matrix leadership to develop, motivate and achieve results through teams; enable development of a resilient attitude, embrace change and have an unwavering commitment to organizational People Strategy
  • Ensure studies are designed to meet regulatory, quality, medical, and access goalsPosition Responsibilities Medical Monitoring
    • Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by
      • Articulating clinical development strategy
      • Analyzing, interpreting, and acting on clinical trial data towards development
      • Serving as principal functional author for Regulatory submissions, study reports, and publications
      • Independently synthesizes and/or contributes to plans (e.g., trial design, development strategy, regulatory strategy) based on merging data and multi-functional input
      • Designs 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 studies Clinical Development Expertise & Strategy
        • Manages multiple/complex active programs concurrently across early development clinical lifecycles
        • Accountable for clinical contribution to the development of indication strategy
        • Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
        • Provides clinical leadership and disease area expertise into integrated disease area strategies
        • Partners closely with KOLs in specific indications
        • Evaluates strategic options against a given Target Product Profile (TPP)
        • Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/Clinical Scientists, and raises to Development Team as needed
        • Sets executional priorities and partners with Clinical Scientists to support executional delivery of studies
        • Accountable for top line data with support of Clinical Scientists and Statisticians
        • Liaises with Clinical Scientists, Translational & Discovery Scientists, and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
        • Liaises with other functions (e.g., Thematic Research Centers and Translational Medicine) and apply foresight and prioritize translational objectives in anticipation of development needs
        • Ad-Hoc involvement in various departmental or enterprise initiatives (e.g., committees, sub-teams etc.)
        • Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio Health Authority Interactions
          • Serves as primary clinical representative in regulatory interactions for early development projects
          • Accountable for clinical contributions to clinical study reports (CSRs), regulatory reports, briefing books and submission documents External Partnerships, Alliances, and Publications
            • Acts as a focal point for defining and establishing relationships with key Global Phase I Centers
            • Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
            • Represents department in business development due diligence and partner alliance management as appropriate; sits on JDC/JRC/JSC as appropriate
            • Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.) Leadership and Matrix Management
              • May be responsible for managing Early Clinical Development Physicians, attracting, developing and retaining top talent; ensures appropriate training and mentoring of Early Clinical Development Physicians
              • Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Degree Requirements
                • Advanced degree(s) in relevant field: MD or MD/PhD and deep clinical expertise in a therapeutic area
                • Fellowship/specialty training in relevant therapeutic area preferred Experience Requirements
                  • 7+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable
                  • Extensive experience in clinical trial design and execution, biomarker development, and development strategy in pharmaceutical industry
                  • Deep understanding of pharmaceutical discovery, development and commercialization
                  • Track record of mentorship and/or management and/or matrix leadership
                  • Demonstrated leadership abilities in a matrix environment Key Competency Requirements
                    • 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 ability to build relationships with external partners, thought leaders and collaborators outside of BMS
                    • Partner and interact with colleagues from Late Development to assure a seamless transition into late stage (Phase II-III trials) Travel Required
                      • Domestic and International travel may be requiredThe starting compensation for this job is a range from $308,000 to $354,000 plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.Final, individual compensation will be decided based on demonstrated experience.Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.#LI-HybridIf 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 CareersWith 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 BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Cambridge , Senior Director, Early Clinical Development (MD) - Neuroscience, Executive , Cambridge, Massachusetts

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