Responsibility

• Lead China BCF team to implement all applicable controls with related SOPs.
• Perform business control risk assessments. Ensure an adequate control environment according to the Internal Control Standards defined by BMS.
• Act as the subject matter expert for all Internal Control related activities and provides assistance to business owners to develop or update Policies and Procedures.
• Supervise and review Sarbanes-Oxley testing and reporting process.  Review documentation and findings performed by the BCF team.
• Collaborate with functional owners to analyze processes and propose improvements
• Collaborative with Regional BCF lead and other country BCF to facilitate best practice sharing, manage standardization projects and support regional analysis function.
• Provide trainings and assistance in the remediation of control issues.
• Lead the quarterly review with China Lead team to present the deficiencies identified through testing and monitoring procedures or as raised by internal and/or external audit.
• Provide assistance to develop remediation plan including detailed procedures, resource requirements and schedule for completion of necessary remediation activities
• Provide assistance to facilitate and co-ordinate internal audit activities
• Ensure compliance with the FCPA (Foreign Corrupt Practices Act) through monitoring and confirmation processes as well as discussions with Local Management and the review of expenses considered relevant for FCPA purposes (T&E and Disbursements).
• Manage the Grant of Authority (GOA) matrix through the review of requests; the periodical review in the corporate policies and pre-established limits.
• Participate in joint meeting with Compliance Team

Requirements

• Experience in internal controls and internal procedures, especially as relevant to FCPA reviews, SOX 404 compliance,  Internal Control/Business Process testing and reviews.
• Demonstrated ability to collaborate with key management and provide guidance on the appropriate resolution of issues Demonstrated understanding of efficient task and project planning techniques
• Demonstrated ability to gain the confidence and cooperation of the local managers to ensure appropriate input and dialogue on potential risks due to inaccurate guidance or monitoring.
• Demonstrated ability to properly plan an apply accounting and auditing concepts in business situations as encountered.
• Demonstrated understanding of internal control environment requirements

• Experience with US GAAP/FASB/IFRS reporting requirements
• Experience and knowledge in commercial and market operation.

• Proficient in critical financial thinking and decision support
• Experience in leading process improvement with cross-functions.
• Knowledge of business application (SAP) and key computer package and consolidation tools (Hyperion) and is proficient in pulling data from these packages for use in relevant analyses.

Responsibilities

Perform necropsy on rodent and non-rodent animals. Trim, fix, process, embed,microtome, and stain tissue specimens.

Assist management with scheduling of necropsy/histology laboratory work.

Enter data into the pathology data collection system, as needed.

Operate and maintain laboratory equipment (e.g., processor, embedding station, autostainer, microtome, coverslipper.) Perform troubleshooting as necessary.

Operate and maintain specialized equipment, (e.g., IHC equipment, laser capture microdissection equipment, and cryostat) with little or no supervision.

Organize histology study specimens and study files for archival with no supervision and assume greater responsibility for assignments of staff to complete archival procedures as directed by the supervisor.

Comply with safety regulations, SOPs, GLPs, and study protocols. Assist with development and revision of SOPs as needed.

Organize and/or conduct quality assurance review of microslides, to assure the task is performed by appropriately trained personnel.

Serve as study coordinator with no supervision and mentor less experienced study coordinators.

Perform advanced investigative methods such as immunohistochemistry and other molecular techniques with little or no supervision.

Organize and/or facilitate the training of personnel in select laboratory procedures.

Conduct inventory of laboratory supplies/chemicals.

Responsible for the review of draft/final study protocols and providing feedback to management. Responsible for review of study files.

Stay current in the field of histology through regular review of literature. Share new techniques that are relevant

May be required to provide supervision of staff members as needed.

Interact with CRO laboratories as needed.

Qualifications

Bachelor’s degree in biological sciences or the equivalent with a minimum of 2-4 years of relevant experience or MS with a minimum of 0-1 year of relevant experience.

Histotechnician (HT) or Histotechnologist (HTL), ASCP certification required.

Experience in tissue trimming, embedding, processing, staining and coverslipping of microslides required.

Independently perform some special microslide staining procedures.

Experience in developing and performing IHC techniques or other molecular techniques with limited supervision would be preferred.

Basic working knowledge of mammalian anatomy.

Must be able to communicate effectively and direct the work of others when working in role of study coordinator.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  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 the resources to pursue their goals, both at work and in their personal lives.

Description:  Drives the successful and timely execution of a clinical research protocol from study start-up to final clinical study report within established budget and timelines using strong project management and organizational skills, monitors protocol progress and addresses and manages obstacles, serves as primary operational contact for the protocol, coordinates the development of protocol level documents and plans, effectively leads a global team of individuals assigned to the protocol; strong interpersonal and influencing skills, proven team-building skills and ability to foster partnerships across projects and multidisciplinary teams, effective oral and written communication skills to influence, inform or guide others.

Comments: Additional PTM support is needed to manage the current BoW for the I-O priority programs. The demand for this program continues to increase with multiple upcoming submissions and an expanding LCM program.

Requirements:  A minimum of a BA or BS Degree with 4 to 6 years of demonstrated project management experience of which at least 2 should have been gained in the pharmaceutical or healthcare industry. This candidate should have leadership experience in the execution of global clinical research trials management.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  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 the resources to pursue their goals, both at work and in their personal lives.

The Vendor Oversight Lead, Global Clinical Trial Business Partnerships is a role considered essential to the sustainability and success of the BMS R&D pipeline.  This role reports to the Associate Director, Global Vendor Oversight & Operations and is a key member of the broader Global Clinical Trial Business Partnerships Team.

This is an individual contributor role who has demonstrated core expertise in the business management of vendor oversight, assessment and due diligence.

Position Responsibilities

Management of vendor oversight requirements and documentation

Project management of vendor assessment & due diligence activities for all GCO vendors

Providing guidance and support activities within global clinical operations (GCO) to team members for all vendor oversight, assessment and due diligence activities

Standardization of vendor oversight requirements and reporting

Training of all processes related to vendor oversight, assessment and due diligence for involved staff

Completes and/or assists with final due diligence reporting

Stakeholder management among cross-functional groups and vendors to ensure team attendance / assistance / expertise

Communicates with all levels of organization

Drive project timelines to ensure project success

Process Improvement to existing methods / Establishing best practices for current SOPs

SOP and guidance document updates

Management /design of vendor database and SharePoint site

Collaborates with Global Procurement regarding sourcing events and awards

Reporting, analysis, special Projects

Responsibility for supporting ongoing vendor oversight and documentation across Clinical Trial Business Partnerships

Experience and Expertise Required

Bachelor’s degree required with an advanced degree preferred

At least 5 years of relevant industry experience, with substantial business experience and experience leading teams

5 years of Project Management experience

Track record of leading through influence, working across complex, global organizational matrices

Demonstrated influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a team

Business, operational, stakeholder management experience

First-hand experience of working directly with Contract Service Providers (CSPs), investigators, customers, opinion leaders and professional staff as well as broad exposure to business in general

Ability to lead others

Demonstrated ability to effectively communicate to a diverse audience at multiple levels within the company

Demonstrated ability of managing and working with cross-functional / teams in a complex, changing environment to deliver value-added results to the organization

Demonstrated ability to define projects, translate it into actionable plans and manage implementation

Experience in change management and process improvement

High level of adaptability in dealing with complex work environments

Balances priorities and multiple demands in a responsive and professional manner

Escalates and keeps leadership aware of status, issues

Drive efficient and effective meetings

Drive communication and training for GCO vendor oversight, assessment and due diligence

Support other groups within GCO as necessary

The Research Associate will join the Oncology Resistance Biology group at Bristol-Myers Squibb in Cambridge, MA and aide in the advancement of early stage therapeutic targets at the intersection of tumor genetics and tumor immunobiology. The position will utilize cellular biological and immunological techniques to screen and validate targets that confer resistance to immunotherapies.

The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to work across a highly matrixed environment to advance preclinical drug development programs from target identification/validation through IND enabling studies. The candidate will be expected to effectively collaborate with colleagues in the oncology, immunology, immuno-oncology, protein engineering/antibody development and medicinal chemistry groups. The successful candidate will demonstrate clear and professional verbal and written communication, capable of presenting scientific results to multidisciplinary teams.

Qualifications

·        A B.S. with a minimum of 2 years of experience, or an M.S. with research experience in cellular biology and/or immunology is required.

·        Demonstrated experience in experimental design, execution, data analysis and troubleshooting are required.

·        Hands on experience with a wide range of cellular biology and immunology assays, including cell culture, flow cytometry, western blotting, ELISA, siRNA/shRNA knockdown, CRISPR-mediated genome editing, qPCR, cloning, cell proliferation assays, lentivirus generation and transduction is required.

·       Experience in utilizing software such as Graph Pad, Flowjo, Microsoft office etc. for data analysis and figure generation is highly desired.

·        Experience with functional genetic and/or small molecule screens and next generation sequencing library preparation is desired.

·        Experience with in vivo/ex vivo pharmacology, including rodent handling and common procedures including tissue processing is desired. 

·        Experience in cancer genome data mining through use of desktop tools/interfaces and public databases (e.g., CBIO, TCGA, CCLE, Genepattern etc) is desirable.

·        Attention to detail with excellent organizational and record keeping skills is a requirement.

·        Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required.

·        This position is located in Cambridge, MA. There will be less than 10% travel.

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Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.

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 the resources to pursue their goals, both at work and in their personal lives.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are a passionate industry leading organization committed to making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents, ideas, and integrity to collaborate and swiftly deliver operational excellence and high-quality data.  We are driven to make a difference, from cutting edge research, to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility, and values diversity and inclusion in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees opportunities for growth, both at work and in their personal lives.

Responsibilities

The Associate Protocol Manager (PTM) is a diverse and challenging role within Global Clinical Operations working in a dynamic matrix project team.

The Associate PTM supports the successful and timely execution of in-house or outsourced clinical research protocols from study start-up to final clinical study report within established budget and timelines.

The Associate PTM works in collaboration with the primary Protocol Manager to monitor protocol progress, address and manage obstacles, and help coordinate the development of protocol level documents and plans.

The Associate PTM can effectively identify issues and risks, and escalates promptly within the protocol team.

The Associate PTM must leverage her/his strong interpersonal and influencing skills to foster partnerships across assigned projects and multidisciplinary teams.

Requirements

A minimum of a BA or BS Degree with 2 to 4 years of demonstrated project management experience of which at least 1 should have been gained in the pharmaceutical or healthcare industry.

Experience working with CROs is a plus.

This candidate should have experience in the execution of clinical research trials management demonstrating strong project management and organizational skills.

The Senior Scientific Advisor is responsible to actively engage with Thought Leaders and to serve as the Therapeutic Area (TA) reference point within their geographic scope. The Sr. SA is responsible to design and deliver the medical plan, develop LR Medical Plan, in collaboration with LR partners define the most the most effective, provide medical support to internal matrix partners, and foster effective and open relationships with the LR partners. Participate actively in price and reimbursement pre-works, discussions, negotiations with government bodies / sick fund in the different therapeutic areas based on the collaboration with the LR partners. Support the development Brand Strategies in collaboration with BMS commercial and LR teams, by communicating medical insight and knowledge about the product or disease area, in particular with reference to patients’ needs and treatment trends.

Location:

Turkey: Istambul, Ankara or Izmir

Qualifications:

•  Medical Degree (Physician), Pharm.Dr. or Science PhD.

Experience and Knowledge desired:

• Expert knowledge of an oncology scientific or clinical area
• Experience in pharmaceutical healthcare environment
• Experience in developing field medical plans aligned with medical and overall disease & product objectives
• Experience in working in the field with HCPs
• Knowledge of local ethical and compliance regulations
• Fluency in English and Turkish

Interested to join BMS in this role? Please submit your CV in English only by 4th of June 2019.

The Scientific Advisor is responsible to actively engage with Thought Leaders and to serve as the Therapeutic Area (TA) reference point within their geographic scope. The SA is responsible to design and deliver the medical plan, define the most effective, provide medical support to internal matrix partners, and foster effective and open relationships. Participate actively in price and reimbursement pre-works, discussions, negotiations with government bodies / sick fund in the different therapeutic areas. Support the development Brand Strategies in collaboration with BMS commercial, by communicating medical insight and knowledge about the product or disease area, in particular with reference to patients’ needs and treatment trends.

Key Role Accountabilities:

External Environment and Customer Focus

• Role model in developing and maintaining peer-to-peer relationships and close contacts with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer unsolicited product and HEOR related questions.
• Master proficiency in available scientific resources and presentations. Effectively present information to HCPs, as appropriate, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives.
• Actively profile the medical and competitive landscape to effectively evolve planning at the market level within the medical team and matrix leadership teams, as appropriate.
• Collect, analyze and present meaningful medical insights back to the medical and commercial organizations at brand team meetings to be actioned in support of the strategy development.

Medical Planning/Execution          

• Deliver scientifically meaningful medical programs proposals and ensure flawless execution of medical activities to support overarching medical plan execution.
• Discuss and deliver Health Economics and Outcomes Research (HEOR) evidence based information reactively (i.e., to government agencies, healthcare organizations, and payers), as appropriate.
• Lead cross functional collaboration within matrix teams to ensure appropriate embedding of the medical perspective and aligned focus in key critical execution to achieve overall medical strategies and objectives.
• Represent medical as a key reference point for internal stakeholders

Compliance

• Endorse and implement a culture of compliance
• Adhere to all internal and external rules and regulations
• Alert management or the Compliance Department to any possible compliance issues
• Act as a role model who demonstrates consistent ethical and professional behaviour

Qualifications:

•  Medical Degree, Physician or Pharmacist

Experience and Knowledge desired:

• Expert knowledge of an oncology scientific or clinical area.
• Expert knowledge of BMS IO products highly desirable.
• Experience in pharmaceutical health care environment.
• Experience in developing field medical plans aligned with medical and overall disease & product objectives 
• Experience in working in the field with HCPs
• Knowledge of local ethical and compliance regulations.
• Fluent in English and Turkish

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  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 the resources to pursue their goals, both at work and in their personal lives.

Description

We are seeking a highly motivated Research Associate to be part of the Translational IHC & Histology Group in Translational Pathology. Members of this team work on various projects in concert with Discovery, Translational Research, Biomarker, Pathology and Pharmacodiagnostics for further development of the BMS Oncology and Immunology pipelines, contributing to target discovery, lead selection, safety assessment, clinical biomarker validation, and indication selection for BMS clinical trials. The successful candidate will be responsible for developing and validating monoplex and multiplex IHC assays, in situ hybridization, and image analysis. She/he will work closely with discovery and translational research scientists, clinical biomarker leads, image analysts and pathologists to develop assays, perform tissue cross-reactivity study and disease profiling, and document assay performance in support of their translation to clinical samples. The candidate will also be responsible for the preparation and qualification of reagents, the assay technology transfer to CROs and other bioanalytical assays as needed to support Translational Research, as well as contribute to the preparation and presentation of scientific findings.

Job Requirements/Education

BS required and MS preferred with 3~5 years of relevant experience in life Science discipline. Applicants from academics and industry will be considered. Preference will be given to individuals with previous experience working in the fields of oncology and immunology and working in a GLP or GCLP environment.

Proven technical expertise in developing and implementing manual or automated immunohistochemistry and in situ hybridization assays. Experience in image analysis, multiplex immunohistochemistry, and laser capture microdissection are highly desirable.

Must be organized and able to work well in a team setting.

Excellent communication skills, both written and verbal are required.

Bristol-Myers Squibb (BMS) is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Ireland, Cruiserath, Dublin 15, approximately a $1 billion investment. The new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.

BMS Cruiserath Biologics is seeking to recruit a permanent QC SO Sample Management Analyst. The successful candidate will be responsible for the sample management process, involving organisation of shipments, receipt and storage of samples, sample aliquoting, management of sample storage units and their temperature monitoring and sample disposal.  In addition, laboratory sample inventory management, Drug Substance reverse programme management and receipt of critical materials.

Responsibilities will include (but not limited to):

• Receipt and aliquoting of samples for the QC activities for Global Biologics Laboratory and Large Scale Cell Culture Facility
• Co-ordination of sample and critical reagent shipments
• Participate in investigations associated with sample handling, receipt and long-term storage
• Management of sample temperature tracking devices
• Management of shipping documentation, electronic and paper logbooks, LIMs/CIMs data.
• Liaising with internal and external stakeholders on testing schedules
• Tracking sample chain of custody in Cruiserath Biologics Laboratory

Qualifications and Experience required:

• A minimum of a B.Sc. in Science related discipline and must have at least 2 years’ experience, in a GMP laboratory setting with sample management experience.
• Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable. 
• Demonstrate good communication, organisation and team-work skills.
• Excellent attention to detail
• The candidate must have experience in electronic systems such as LIMs/CIMs and SAP.

• Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level. The BMS Behaviours are: Passion, Innovation, Accountability and Speed.

Why should you apply:

• You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days,  life assurance and gain-sharing bonus

​Join us and make a difference

At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

 We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.