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Associate Director DMPK Project Representative

Company: Disability Solutions
Location: Cambridge
Posted on: July 2, 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 .Scientific Associate Director, DMPK Project Representative Challenging. 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.Within the Pharmaceutical Candidate Optimization (PCO) organization at BMS, the Development DMPK Team provides ADME (absorption, distribution, metabolism, and excretion) and PK (pharmacokinetics) support for all pipeline assets throughout clinical development, from candidate nomination through registration and lifecycle management. The Dev DMPK team is responsible for characterizing the ADME properties, and drug-interaction potential of drug candidates. Working closely with drug safety and clinical pharmacology, Dev DMPK plays a critical role in IND submissions and marketing authorization applications. We utilize our deep expertise in ADME and PK to collaborate with peer R&D functions to identify and solve issues, enable clinical development and successful marketing authorizations across the globe. PCO is looking for a Scientific Associate Director to join the Dev DMPK group that is an expert in ADME and pharmaceutical drug development of protein therapeutics and small molecule drugs. In this role, you will represent the Dev DMPK function on cross-functional development project teams; oversee developmental drug disposition metabolism and non-clinical pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier/responses; and assist in developing strategy for the group. You will collaborate with discovery team in PCO, Toxicology, Biopharmaceutic, Bioanalytical, Clinical Pharmacology to ensure transition from discovery to First-In-Human and address drug development issues. Key Responsibilities In the role, the ideal candidate:

  • Represents Dev DMPK on cross-functional development project teams for biologics and small molecule therapeutics, including preparing project strategies and development plans.
  • Oversees internal and outsourced nonclinical drug metabolism and PK activities on multiple projects, including study design, data interpretation, report preparation.
  • Writes and critically reviews nonclinical submission documents such as CTD sections for INDs and NDAs/BLAs, Investigator Brochures, briefing books, DSUR, etc. to support clinical trials and global drug registrations. Interact s with regulatory authorities to address questions as needed.
  • Support clinical assets for all ADME and PK related inquiries and activities.
  • Assists in guiding department strategy. Supervising and/or mentoring junior scientists may also be required. Basic Qualifications: Bachelor's Degree with 12+ years of academic and / or industry experience OR Master's Degree with 10+ years of academic and / or industry experience OR Ph.D. or equivalent advanced degree in the Life Sciences with 8 + years of academic and / or industry experience. Plus 4 years of leadership experience. Preferred Qualifications
    • PhD degree in pharmaceutics, biochemistry, chemistry, biology or related fields, and 8+ or more years of relevant drug discovery and development experience within the pharmaceutical Plus 4+ years of leadership experience
    • Experience with preclinical PK and PK/PD modeling for biologics is a plus.
    • Extensive expertise in drug disposition and small molecule therapeutics , including understanding of in vitro and in vivo techniques used to characterize ADME properties of drug candidates, and factors that impact large molecule PK (TMDD and ADA) .
    • A thorough understanding of drug development of biologics and small molecule therapeutics
    • Working knowledge of bioanalysis.
    • Working knowledge of PK/PD concepts and models, as well as proficiency in human PK and dose prediction.
    • Effective at independently working with interdisciplinary project teams, including developing ADME strategies and implementing drug development plans.
    • Understanding of regulatory requirements in the areas of drug metabolism, drug-drug interactions, bioanalysis, toxicology, and clinical pharmacology.
    • Experience preparing drug metabolism reports and regulatory submission documents.
    • Experience overseeing studies performed internally or at external CROs.
    • Strong written and verbal communication skills. 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 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 , Associate Director DMPK Project Representative, Executive , Cambridge, Massachusetts

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