Bristol Myers Squibb Senior Manager/Associate Director, Clinical Research Pharmacist in Princeton, New Jersey
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.
Purpose/Objective of the job
Provide pharmacy expertise in the development and management of investigational product at a program and protocol level (i.e pharmacymanuals for utilization by clinical sites)•Provide expertise across Clinical Supply Chain and Clinical Supplies Operations on clinical site/pharmacy operations; aseptic preparation guidelines for injectables; onsite compounding.
Support Clinical Supply Chain and Global Clinical Operations and Pharmaceutical Development on the development of clinical study protocols. Provide clinical pharmacy guidance with the handling, preparation and administration of investigational products at clinical sites
Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products
Key Responsibilities and Major Duties
Provide support to GDO (Global Development Operations) on the development of clinical study protocols, specifically providing clinical pharmacy guidance with the handling, preparation and administration of investigational products at clinical sites.
Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.
Educate clinical site personnel through in-services, investigator meetings and clinical site initiations or follow-up visits on the proper handling and use of investigational products, when necessary.
Provide consultation to clinical project teams on medication/device related issues, such as concomitant medications, exclusionary medications and patient compliance/adherence issues.
Provide clinical pharmacy expertise on CSC/CSPL (Clinical Supply Chain/Clinical Supply Program Leadership)program planning meetings
Interface with the clinical teams to determining site capability and feasibility prior to site selection for assigned compound/clinical protocols, participates in risk assessments surrounding drug preparation and offers mitigation strategies.
Liaises with Global Quality and Regulatory Compliance to ensure applied pharmacy practices align with local regulatory guidelines.
Interacts with Medical and Commercial teams to provide pharmacy expertise and guidance to support answers to questions from clinical or commercial site pharmacies.
Provides expertise to address questions surrounding preparation or storage for BMS products or comparators provided for in GDO sponsored clinical trials
As subject matter expert, interfaces with the clinical team in determining site capability and feasibility prior to site selection for on-site compounding, excipient and ancillary supply, and other special supply considerations. Liaises with Quality Assurance to ensure audit completion prior to study start as required.
Interacts with OPD (Oral Product Development) for onsite compounding instructions and Global Regulatory Sciences with respect to country regulations.
As assigned, support CMR and demand activity for all assets that use the PET tracer technology in Radio-pharmacies.
Interacts with PD (Product Development), PPD (Parenteral Product Development) and Strategic Innovation to provide practical pharmacy expertise and experience to be used to help develop use time studies and practical product preparation methods.
Additional tasks within scope of expertise and experience as assigned by supervisor in pursuit of BMS goals
Degree in Pharmacy (Pharm D preferred) with 5 -7 years of Clinical Pharmacy or equivalent pharmaceutical/biotech industry experience.
Completion of a post-PharmD Industry Fellowship or pharmacy practice residency and hospital pharmacy experience is desired. Clinical Research experience preferred.
Knowledge of pharmaceutical science normally attained through the achievement of a Pharm D, Bachelor’s degree in Pharmacy or related science and a minimum of 5-10 years of experience in the pharmaceutical industry with a focus in clinical supplies
Excellent knowledge of clinical studies and the global clinical supply processes; viewed by peers as a leader with a high level of respectability and complete knowledge of processes and strategies
Demonstrated ability to work with and manage people/teams in a culturally diverse, complex, changing environment
Demonstrated ability to effectively communicate and influence others to accomplish goals and objectives
Demonstrated ability to develop others through leading by example
Demonstrated ability to apply PD operating philosophy and operate within policies and procedures.
Knowledge of cGMP and GCP regulations, ICH Guidelines as it relates to Good Distribution Practices (GDPs) and local country drug regulations.
Demonstrated broad computer program literacy, Microsoft Suite (Office, Excel, PowerPoint, SAP, IRIS, TrackWise, Document, IRT/IVRS System Knowledge, CTMS (ECLIPSE
Around 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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1548236
Updated: 2021-12-08 02:57:06.960 UTC
Location: Princeton,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Bristol Myers Squibb
- Bristol Myers Squibb Jobs