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.

The Associate Director, Global Policy Partnerships, will identify and leverage new strategic policy collaboration opportunities with global health stakeholders and support driving externally facing policy partnerships that are influential in shaping the policy landscape towards sustainable and patient-centric healthcare (considering BMS key therapeutic areas). Key activities include coordinating work of existing policy partnerships, identifying and helping to develop externally facing global health engagement programmes, asserting companywide policy positions, and establishing impact metrics. This individual will also represent BMS in external fora and stakeholder alliances on global health challenges, health system sustainability, scaling up NCDs best practice and efficiency of healthcare issues. Internally the individual will lead various policy partnership programs with BMS market colleagues.

Responsibilities will include, but are not limited to, the following:

• Global Policy Partnerships: Support development of global multi-stakeholders policy coalitions/platforms e.g. and not limited to, All.Can International in 22+ markets and Access Accelerated in LMICs, whilst aligning closely with matrix functions (HEOR, R&D, Access, BI&A, BMSF,CA) ensuring policy outcomes that shape the environment in favor of patient access to innovation as well as improved value appraisal and patient/societal outcomes, demonstrate concrete policy and care solutions that support sustainability and resilience of healthcare systems. Works closely with company PGA leads in the markets and regionally to monitor and identify the most critical global health policy issues and solicit and incorporate their input. Support BMS representation at Access Accelerated Steering Committee and All.Can Board.

• Global Policy Engagement: Develop strategically aligned Global Health Policy Engagement opportunities and prepare senior leadership briefings for their attendance at mainly with Geneva, Paris, Brussels based organizations (WHO, OECD etc.).  Regularly monitoring World Health Assembly developments as well as NCD related policies especially and respective strategic partnerships management, C/Can, Access Accelerated etc.

• BMS Global Health Policy Partnerships Community of Practice: Ensure strategic alignment across BMS and organize regular internal program specific workshops for +22 markets worldwide (e.g. All.Can, Access Accelerated), and develop content for Community of Practice meetings. Ensures close cooperation with the matrix including Franchises, Markets, CA-IR, Access, R&D, BI&A, Legal, BMSF, GPS, to support optimal patient access to innovation/resource allocation. Identify and develop policy communication opportunities by working closely Policy Communications.

Requirements required:

• 6+ years of experience in a similar position preferably in the healthcare sector with a minimum of 3 years direct experience working with (and/or within) national governments and institutions or advocacy organizations, developing and/or influencing public policy.
• Experience in working in oncology, cardiovascular, rare diseases and / or virology is a plus.
• Good knowledge of healthcare systems, health, especially NCD policy dynamics around access and digital health as enabler in biomedical research.
• MBA, Master or Bachelor or advanced degree in business, economics, health policy or relevant area.
• Demonstrated ability to lead cross-functional cross-cultural matrix teams, and stakeholders towards consensus.
• Strong entrepreneurial mindset, strategic planning, effective communications and programme management skills.

Skills required:

• Has experience in the areas of global health policy / government affairs and alliance development as well as knowledge of EU,  US and global health (LMIC) policy issues
• Mastery of policy processes and a clear understanding of how to influence key decision makers effectively
• Understanding of healthcare systems, and NCD policies, digital health in shaping health outcomes. Proficiency in English (written and spoken). Other languages are an asset
• Knowledge of the operations and issues associated with the pharmaceutical business model as well as healthcare systems, and medicines supply chain related organizational and policy issues.
• Has a demonstrated ability to drive complex projects/programmes forward in a cross-functional environment, and measure return on objectives in short, mid and long term
• Has excellent communication, collaboration, interpersonal, and organizational skills
• Has strong strategic thinking skills and business acumen
• Is motivated, highly accountable, and resourceful
• Strongly identifies with BMS values and behaviors
• Bachelor degree level required, advanced education a plus (areas including health policy, public health, economics, business or other relevant area)

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.

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.

Department Title and Description

Research and Development Quality (R&D Quality)

• Define and oversee the global quality strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems (QMS) are implemented and in use;
• Translate QMS elements into the R&D processes and ensure feedback to the central QMS team;
• Lead the Quality and Compliance R&D Escalation Process;
• Ensure GLP systems are in place, studies are audited and lead analytical path of Translational Medicine;
• Oversee the Data generation and data integrity from laboratory work and non-clinical phase projects;
• Ensure Quality is Designed into non-clinical trials and clinical protocols using data and information from discovery phase, non-clinical and clinical studies;
• Oversee process development, manufacturing and release of clinical supplies to clinical trials protocols;
• Advice on Franchises (including Cell Therapy) and Clinical Operations development projects;
• Lead Qualification of vendors and manage external Quality Systems;
• Execute GCP and Pharmacovigilance (PV) audits and support GCP and PVRegulatory inspections;
• Ensure that GxP follow-up CAPA activities are completed;
• Oversee study centers, countries, investigators and connect with PV, Medical Affairs (MA) and Regulatory Affairs (RA);
• Contribute to develop Q M S training elements.    

The PV and Lifecycle Management Quality pillar in RDQ provides independent quality oversight on the clinical safety/PV, RA and MA QMS applied during the lifecycle of products, managed by global internal and external stakeholders.

In addition to providing PV, RA, MA quality SME consultancy, the primary focus of the group is to:

• Continuously monitor the health of the QMS and initiate actions where needed;
• Watch Health Authority commitments, submission strategies and the planning/execution thereof;
• Manage/support Health Authority inspections;
• Execute risk-based audits.

Purpose/Objective of the job

Key responsibilities of the Associate Director Inspection Management Lead, (GCP/GVP) PV & LCM Quality include:

1) Preparation, management and follow-up of Health Authority Sponsor / MAH inspections, with focus on the global PV system, interactions across GxP and the supporting QMS;

2) Conducts inspection risk assessments, prepares for and coordinates all types of GCP inspections (including routine, directed or submission related inspections) and leads business critical GCP inspections (in collaboration with other GxP audit and compliance functions and RDQ Quality Operations, as appropriate);

3) Review of Corrective and Preventative Action Plans (CAPA) to address findings from Health Authority inspections;

4) Develop, deliver and support inspection readiness training sessions;

5) Follow-up on learnings from inspection preparation and management experience, with focus on strategic and highly complex issues;

6) Oversee changes in global pharmaceutical legislation and the impact on the BMS global PV system, GCP and QMS through, e.g. PEARL;

7) Serve as a subject matter expert on Clinical Development & PV related topics;

8) Establish strong partnership with business stakeholders.

Key Responsibilities and Major Duties

• Participate in the preparation, hosting and follow-up of regulatory authority inspections related to clinical development, clinical safety and pharmacovigilance activities at central sites, affiliates and partners/vendors, as assigned;
• Creates and maintains an inspection toolbox to facilitate the coordination of worldwide Health Authority GCP/ GVP inspections;
• Ensures strategic inspection preparation with all stakeholders focused on areas of highest impact through e.g. the conduct of mock inspection and preparation of story boards;
• Conducts pre-inspection visits and/or sponsor assessments, as needed;
• Maintain an in-depth knowledge of regulations as they apply throughout a product’s life cycle, with primary focus on clinical development, clinical safety/PV, and act as an expert resource/trainer;
• Participate in GPS and/or BMS company process- and improvement initiatives, as assigned;
• Lead or co-lead compliance Investigations, as assigned;
• Directly supervise inspection management staff, including responsibility for providing ongoing guidance, development and performance assessment and/or manage a local audit function as assigned;
• Provide mentoring for new staff, as assigned;
• Represent the RDQ- CT/ PV & Lifecycle Management Quality position during internal and external meetings, as required;
• Partner with quality leads involved in Clinical Development, RA and MA activities, throughout the product lifecycle
  • Assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the QMS where necessary
  • Identify and drive continuous quality process improvements
  • Integrate end –to end quality principles;
• Establish strong partnership with business stakeholder
  • Seek to understand and evaluate their priorities
  • Actively participate in and make meaningful contributions
  • Deliver independent expert support and propose solutions
  • Present key data (compliance, conformance, issues and risks) to drive decision making;
• Act as an expert and advise on clinical development, clinical safety/ pharmacovigilance related matters:
  • Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.

• Other
• Act as an advisor and back-up to the (Associate) Director, Inspection Management Lead, PV and Lifecycle Management Quality;
• Lead or contribute to multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline;
• Lead or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department;
• Act as a credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the line or cross-lines;
• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation;
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level;
• Provide input in the global audit plans based on identified signals/trends/risks/gaps;
• May influence the external environment through interactions with regulators, trade associations, or professional societies;
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems;

• (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship):

N/A

Key Stakeholders/Contacts – describe this position’s key internal matrix relationships and key external stakeholders/clients

• Interaction with peers in R&D Quality, Global Quality and GPS
• Interaction within R&D, incl. Worldwide Patient Safety, Global Drug Development, Regulatory Affairs, Medical Affairs, Commercial, in relation to GCP/PV audits, CAPA and PV training;
• External engagement as agreed with industry/trade/QA associations, and pharmaceutical company peers;
• Internal engagement as needed with relevant R&D partners and corporate functions

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.

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.

• Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) intermediate product manufacturing.
• Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions, master service and/or quality agreements and applicable regulatory requirements.
• Responsible for batch record review for intermediate disposition
• Responsible for review and approval of CMO deviation investigations, CAPA, controlled documents (Master Batch Records)
• Act as QA impact assessor and reviewer/approver of CMO related changes
• Support in data auditing and review of protocol/reports in support of regulatory submissions
• Develop and review/approve annual product review reports generated by CMOs
• Collaborate with Global Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from BMS’s audits
• Partner with stakeholders across different operational functions to define projects in order to improve processes and represent the quality organization in implementation phase
• Drive, lead and oversee quality related improvement projects in collaboration with affected CMO functions
• Support in setting and follow up of CMO related key performance indicators (KPI) and metrics
• Provide Quality oversight of routine operations for distribution center responsible for disposition and distribution of finished cell therapy product (CAR-T) in Japan
• Partner and provide support to the Responsible Person for Quality Assurance of commercial product (Hinseki) with respect to finished drug product release for Japan

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.

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.

We are seeking a Clinical Trial Associate to join our high performing team, well regarded for their global contribution to clinical studies. This position will manage the administrative and business activities related to the conduct of clinical trials (registrational and non- registrational /Investigator Sponsored Research Studies) with investigative sites from study start-up to study closure.  

Responsibilities:

• Setting up vendors during study start up period (operational details from sites).

• Enter necessary data / tracking in systems (i.e.ECLIPSE, eTMF, SAP).

• Responsible for documentation within the electronic master file (uploading / completing documents)  & other systems (i.e., document exchange portals like Mytrials/Shared Investigator Portal) including conduct of completeness checks.

• Arranging drug and non-drug (Lab kits, ECG) importation to support study site.

• Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO.

• Collect and distribute documents from / to sites during study life cycle.

• Coordinate study related materials (i.e. protocol, Informed Consent Form (ICF), patient material) for translation. 

• Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding.

• Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)

• Obtain Insurance certificates.

• Preparing on Site Investigator File and other study related file.

• Support equipment calibration and tracking.

• Archiving process handling at study closure.

• May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval.  This could include preparation and/or submission of substantial amendments.

• May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB).

• May support Health Authority inspection and pre-inspection activities.

• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.

 (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

Key Stakeholders:

External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors, Contract Research Organizations, GCP Officer (China only).

Internal: Protocol Manager (PTM), Clinical Trial Managers (CT Mgrs) Clinical Trial Monitors (CTMs), Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers,  Regional Clinical Compliance Leads, Line Managers, Heads of Clinical Operations and Local Regulatory .

Qualifications, experience and competencies:

• Degree within Life Sciences area, Administrative, Financial or Accounting related field.

•  1 - 3 years' experience in Clinical Research or related work experience.

• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred.

• Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…) preferred.

• Basic understanding of GCPs, ICH Guidelines and local regulations as they apply.

• Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.

• Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.

• Demonstrates ability to function independently.

• General knowledge of software systems and web-based applications. Good computer aptitude and willingness to learn new systems and applications.

• Good verbal and written communication skills (both in English and local language).

• Software that must be used independently and without assistance(Microsoft Suite, Clinical Trial Management, System (CTMS),Electronic Trial Master File System (eTMF),Document Exchange Portals ).

BMS offers flexible work arrangements with a 50:50 split remote and office.

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.

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.

We are seeking talented hematology and oncology sales professionals with a proven track record and the drive and initiative to sell in markets that revolve around complex science.  BMS has been consistently ranked as one of top sales forces in the industry, because of the knowledge and support the sales team demonstrate to improving the lives of the patients we serve. BMS is an organization that not only recognizes performance, but also the manner in which performance is achieved.

Hematology Territory Business Managers are responsible for achieving all territory sales goals through the promotion, sale and support of company products or services in his/her geographic territory.

Responsibilities include:

• Communicating with physicians and health care professionals in support of approved product indications.
• Providing customers with assistance in the best application of products: answers all questions concerning products, with appropriate referrals where required.
• Preparing and implementing a comprehensive business plan for territory.
• Contacting prospects and explaining features and benefits of products offered, utilizing persuasive sales techniques all within the boundaries of the BMS Promotional Policy.
• Collaborating with a variety of internal cross functional partners to include clinical nurse consultants, patient support specialists, marketers, account managers, advocate development managers, professional alliance managers and clinical liaisons.
• Planning and organizing promotional speakers programs in territory in partnership with Speakers Bureau vendor and advocate development managers.
• Communicating competitive market intelligence to brand teams and management. 

Required Skills/Knowledge:

• BS in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry with at least two years of related hematology/oncology sales strongly preferred (or proven success in medical field).
• Proven track record that demonstrates top sales accomplishments.
• Demonstrated ability to understand and communicate technical clinical material clearly and effectively.
• Ability to develop critical relationships with physicians, nurses and ancillary staff within academic hospitals, clinics, and private practice facilities.
• Demonstrated understanding of oncology therapeutic area, products and marketplace.
• Demonstrated knowledge of healthcare system processes including reimbursement.
• Strong work ethic and ability to develop priorities and manage time appropriately.
• Ability to work successfully within a team environment.
• Ability to integrate innovative ideas to accomplish corporate and individual objectives.
• Prefer individuals with the desire/ability to relocate for roles of different scope or responsibility.
• Occasional overnight travel is required.
• As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.

In Compliance with Colorado’s Equal Pay for Equal Work Act, see compensation and benefits below:

The base compensation is a minimum $104,180+ sales incentive (role may my eligible for long term incentive depending on level and performance); all compensation will be determined commensurate with demonstrated experience.  For a link to our benefits, please visit: https://careers.bms.com/working-with-us#collapseEleven 

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. 

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 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.

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.

We are seeking talented hematology and oncology sales professionals with a proven track record and the drive and initiative to sell in markets that revolve around complex science.  BMS has been consistently ranked as one of top sales forces in the industry, because of the knowledge and support the sales team demonstrate to improving the lives of the patients we serve. BMS is an organization that not only recognizes performance, but also the manner in which performance is achieved.

Hematology Territory Business Managers are responsible for achieving all territory sales goals through the promotion, sale and support of company products or services in his/her geographic territory.

Responsibilities include:

• Communicating with physicians and health care professionals in support of approved product indications.
• Providing customers with assistance in the best application of products: answers all questions concerning products, with appropriate referrals where required.
• Preparing and implementing a comprehensive business plan for territory.
• Contacting prospects and explaining features and benefits of products offered, utilizing persuasive sales techniques all within the boundaries of the BMS Promotional Policy.
• Collaborating with a variety of internal cross functional partners to include clinical nurse consultants, patient support specialists, marketers, account managers, advocate development managers, professional alliance managers and clinical liaisons.
• Planning and organizing promotional speakers programs in territory in partnership with Speakers Bureau vendor and advocate development managers.
• Communicating competitive market intelligence to brand teams and management. 

Required Skills/Knowledge:

• BS in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry with at least two years of related hematology/oncology sales strongly preferred (or proven success in medical field).
• Proven track record that demonstrates top sales accomplishments.
• Demonstrated ability to understand and communicate technical clinical material clearly and effectively.
• Ability to develop critical relationships with physicians, nurses and ancillary staff within academic hospitals, clinics, and private practice facilities.
• Demonstrated understanding of oncology therapeutic area, products and marketplace.
• Demonstrated knowledge of healthcare system processes including reimbursement.
• Strong work ethic and ability to develop priorities and manage time appropriately.
• Ability to work successfully within a team environment.
• Ability to integrate innovative ideas to accomplish corporate and individual objectives.
• Prefer individuals with the desire/ability to relocate for roles of different scope or responsibility.
• Occasional overnight travel is required.
• As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.

In Compliance with Colorado’s Equal Pay for Equal Work Act, see compensation and benefits below:

The base compensation is a minimum $104,180+ sales incentive (role may my eligible for long term incentive depending on level and performance); all compensation will be determined commensurate with demonstrated experience.  For a link to our benefits, please visit: https://careers.bms.com/working-with-us#collapseEleven 

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. 

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 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.

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.

• Contribuir significativamente al equipo de estudio y al personal del sitio de entrenadores para mejorar el rendimiento del sitio y del centro.
• Servir como un recurso clave para los colegas, proporcionando orientación, capacitación líder y tutoría a otros miembros del equipo a través de un proceso de tutoría mediante presentaciones formales e informales.

• Ayudar a la gerencia en diversas tareas, según se le asigne o solicite.

Busque de manera proactiva mejorar las habilidades de comunicación tanto con las partes internas (nivel global) como con todas las partes externas relevantes y entrene a otros para que hagan lo mismo.

• Identifica nuevos investigadores potenciales, a través de colaboraciones continuas con partes interesadas internas y externas. Evalúa investigadores potenciales y sus sitios para asegurarse de que tengan los recursos y las capacidades para realizar ensayos clínicos. Documenta la visita y comunica los hallazgos. Proporciona comentarios sobre los hallazgos de la Evaluación potencial del sitio a los colaboradores. Recomienda sitios durante el proceso de viabilidad y / o selección del sitio.
• Desarrolla nuevos sitios, que tienen una experiencia mínima en investigación, brindando apoyo para comprender los requisitos para ejecutar ensayos clínicos (es decir, SOP, capacitación, recursos de personal, etc.)
• Determina la necesidad y / o el tipo de visita previa al estudio que se requiere según la experiencia previa del sitio con la ejecución de ensayos clínicos de BMS.
• Realiza visitas de iniciación en colaboración con otros miembros del equipo de estudio y grupos funcionales auxiliares. Proporciona capacitación individualizada y específica del protocolo basada en la experiencia del investigador y del personal del sitio, antes de la activación del sitio.
• Revisa las actividades y la calidad del sitio a través de visitas al sitio y fuera del sitio. Realiza actividades de monitoreo y garantiza la seguridad y protección de los sujetos del estudio de acuerdo con el plan de monitoreo, los PBPD de BMS y las mejores prácticas, el protocolo, las Directrices ICH / GCP y otras regulaciones locales según corresponda.
• Realice actividades de Monitoreo de sitio no cegado para proteger a los ciegos del estudio actuando como una fuente de monitoreo secundaria separada del monitor ciego. Incluye actividades de monitoreo del sitio para farmacia, revisión de aleatorización, responsabilidad de medicamentos y conciliación de los productos de investigación cegados. Trabajar con el personal del estudio no ciego, incluidos farmacéuticos o preparadores de medicamentos no ciegos, y comunicarse solo con el personal interno del estudio BMS no ciego durante la realización del estudio.
• Si bien el monitoreo demuestra la capacidad de usar datos para evaluar riesgos, identificar problemas y tomar decisiones apropiadas. Identifica los factores clave y la importancia relativa de un problema. Analice la causa raíz y el sesgo potencial. Busca información adecuada y crea un plan de acción correctivo o preventivo y comunica el proceso de manera lógica y oportuna.
• Realiza actividades de cierre del sitio cuando se completan todas las visitas de protocolo requeridas y el seguimiento.
• Administra múltiples protocolos, en múltiples áreas terapéuticas, que pueden requerir viajes, según la ubicación del sitio asignado y / o el territorio geográfico.
• Asegura la calidad de los datos enviados desde los sitios de estudio y asegura la vigencia de los datos mediante el uso de los sistemas disponibles para seguir las actividades del sitio.
• La revisión del listado de datos clínicos se realiza en los puntos de tiempo asignados de acuerdo con el plan de revisión de datos y / o SMP
• Supervisa las actividades generales del personal del sitio sobre el que no hay autoridad directa.
• Motiva / influye en el sitio para cumplir con los objetivos del estudio, incluidas las metas de inscripción y retención. Demuestra flexibilidad y adaptabilidad al comunicarse con diferentes partes interesadas utilizando el método de comunicación más apropiado.
• Anticipa, identifica y apoya proactivamente al sitio en la resolución de problemas a medida que ocurren. Documenta de manera adecuada y escala de manera oportuna los problemas pendientes graves o persistentes a la administración y al equipo del proyecto. Inicia, recomienda, documenta y comunica acciones correctivas según sea necesario y realiza un seguimiento para garantizar que se implementen las acciones correctivas / preventivas basadas en el análisis de la causa raíz.
• Participación en el proceso de auditoría / inspección de Cumplimiento Normativo, según sea necesario. Esto incluye el desarrollo e implementación de acciones correctivas y preventivas en el sitio.
• Prepara y presenta informes escritos, tanto de seguimiento como administrativos, de manera oportuna, precisa, concisa, profesional y objetiva.
• Construye, cultiva y mantiene relaciones con los clientes e identifica sinergias entre las necesidades del cliente y los intereses de la empresa.
• Genera confianza con los clientes sirviendo como un recurso consistente y preciso.
• Identificar y resolver proactivamente problemas potenciales tanto a nivel de sitio como de país / centro.
• Colaborar con CTM y / o la gerencia de línea para ayudar en la resolución de problemas más complejos.
 

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.

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.

This role is responsible for being the Point of Contact for Functional Service Provider Clinical Site Managers. Provides oversight to 12-14 Clinical Site Managers performing services for BMS on behalf of Functional Service Provider vendors. Responsible for identification of FSP talent and resource optimization and retention.  Liaises with FSP vendor to ensure quality candidates are being presented for open positions, and participates in bi-directional feedback on FSP staff. Partners with FSP Vendors to align on strategy and operationalization of FSP model.

As member of RCO US Site Management eSLT, responsible for leading and or participating in department level continuous improvement initiatives.  Participates in resourcing decisions in alignment with R&D project prioritization.

Qualifications:

• Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy with 7-10 years of clinically related or relevant experience.
• Experience with leadership, resource allocation and balancing demand of the project and department.
• Thorough understanding of ICH/GCP guidelines and regulations as they relate to protocol/site management.
• Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.
• Knowledge of the pharmaceutical industry and the pre-clinical, clinical, regulatory and commercial components.
• A detailed understanding of project planning and management methods.
• Experience in people management and/or coaching and mentoring.

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. 

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 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.

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.

Position Responsibilities

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:

Project Management

• Directs and delegates to assigned Global Trial Management staff as applicable.

• Drives study execution utilizing available performance metrics and quality indicators (e.g. CTMS, eTMF reports, RBM reports), and study milestones and drivers.

• Develops, manages, and maintains study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.

• Proactively identifies potential risks, develops/implements actions, and makes the appropriate trade-offs of balancing risks with study deliverables and costs.

• Maintains and updates data as appropriate in project management tools including CTMS.

• Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and recruitment status and raises potential issues/mitigation.

• Requires minimal oversight to lead/manage projects.

• Identifies, participates and/or leads initiatives with cross-functional/global teams.

• Leads Study Team meetings, defines the agenda, captures meeting minutes, and facilitates cross-functional discussions.

• Creates, maintains, and implements project management tools at the study level (e.g. actions, decisions, issues log and risk management plan).

• Proficiency in study tools including electronic system skills – e.g. CTMS/eTMF.

• Demonstrated project management and organizational skills with strong presentation and communication abilities.

• Ability to manage multiple deliverables and nimbly respond to changing business demands.

Management Competencies

• Understands interdependencies, links possible solutions, and escalates issues with proposed solutions to appropriate people.

• Reacts with a sense of urgency and responds appropriately.

• Critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.

• Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams.

• Adaptable and flexible—willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism.

• Has the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of BMS (as appropriate).

• Has the ability to review, interpret, and analyze information to support discussions and make decisions.

• Ability to effectively lead a cross-functional team in a matrix environment.

• Time management skills - ability to effectively multi-task and set priorities with minimal guidance.

• Comes with ideas or perspectives when seeking guidance from Operations Portfolio Leads and/or other team members.

• Fosters a continuous learning mindset.

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. 

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 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.

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.

Bristol-Myers Squibb is the industry leader in immuno-oncology with life-saving medicines and a rich clinical portfolio of diverse modalities including monoclonal antibody, antibody drug conjugate, fusion protein, and combination regimes. We are seeking an In Vivo Scientist to join our dynamic, fast paced team involved in collaborating with investigators on research projects, providing daily health assessments, ensuring compliance with regulations/guidelines and maintaining the appropriate documentation. The candidate will have the opportunity to actively participate in veterinary clinical and technical research support procedures.

Position Responsibilities:

• Provide a high level of in vivo scientific and technical support to investigators.

• Assist in designing and coordinating in vivo experiments, drafting and implementing protocols, executing studies, organizing data, analyzing results, and drafting reports/delivering presentations.

• Collaborate with the veterinary and investigative staff on research projects, primarily pre-clinical study conduct; operate laboratory equipment and software applications used for collecting clinical data; provide support and training on technical procedures for investigative staff; understand the active research activities; and provide surgical and anesthesia assistance as needed.

• Serve as a subject matter expert in various biomethodology techniques for training and competency/proficiency assessments to support the VS training program.

• When needed, conduct training sessions (wet lab and classroom) covering species-specific biomethodology techniques with an emphasis around animal welfare and safety expectations.

• Maintains full ownership of assigned area(s) of responsibility as subject matter expert requiring minimal manager/supervisor oversight. 

• Provide treatments, clinical observations, daily clinical veterinary care (clinical health evaluations, basic medical treatments, diagnostic and technical laboratory procedures) and maintain records for laboratory animals in our clinical records system, and under the guidance of a veterinarian, make basic clinical decisions

• Perform specialized diagnostics to assist in the veterinary care program and undergo training to review and interpret basic diagnostic results. 

• Review relevant Standard Operating Procedures to ensure compliance with external guidelines and regulations governing animal care and use.

• Instrumental to upholding regulatory and welfare standards as they pertain to laboratory animal care, husbandry, facilities, and the overall animal macroenvironment.

• Support the Veterinary Sciences Program of Veterinary Care through clinical care management and critical/emergency care on-call duties

• Some travel may be required

• Weekend/holiday coverage may be required on a rotating schedule

Competencies – Knowledge, Skills, Abilities:

• Often provides technical direction, project coordination, and has oversight responsibility of other team members

• Is highly skilled in routine and complex veterinary clinical veterinary and technical research support procedures requiring no supervision.

• Must have a good understanding of research animal facility operations to include animal welfare practices, husbandry procedures, enrichment programs, and applicable regulations.

• Must have strong verbal and written communication skills, excellent organizational skills, and exceptional attention to detail.

• Able to train others to operate standard and complex equipment and perform routine and complex clinical veterinary and technical research support procedures within an animal research facility.

Experience – Responsibility and minimum number of years:

• Must have an exceptional understanding of the biology and proper handling of various laboratory animal species typically attained with 3-6+ years relevant experience in a laboratory animal facility or equivalent.

Qualifications:

• Bachelors of Science (BS) in a life sciences field of study is required

• Laboratory Animal Technician (LAT) certification from AALAS is required

• Registered Veterinary Technician (RVT) is  preferred

Who Should Apply:

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. 

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 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.