Senior Product Manager, IO- GU, US Marketing Team

Summary

This individual will support the development of professional promotional plans and resources for the BMS Immuno-Oncology portfolio in RCC and Bladder, with a primary focus on the continued growth of Opdivo+Yervoy in 1L RCC. 

Responsibilities will include

Driving market research and interacting with customer-facing teams to mine customer insights

Leading the development of professional promotional strategy and materials

Liaising with Worldwide and leading US competitive scenario planning for potential future competitor entrants

Serving as the tumor lead input into sales force training

Working closely with other members of the I-O matrix team (i.e., medical strategy, sales training, sales operations ,patient channel marketing, launch excellence team, payer marketing, market research, and project management) to ensure successful and timely execution

Working collaboratively with medical, legal and promotional compliance team (PReP) to develop and execute high impact marketing materials

Ensuring strong alignment and integration with the Worldwide Commercial Team and worldwide markets as well as other US commercial teams including other tumors, pan tumor, and biomarkers.

Managing communications and making strategic recommendations based on key medical and clinical updates from Congresses and Publications

Interacting with top US and Worldwide Thought-Leaders to understand current treatment landscape, informing key commercial decisions

Working closely with the field to support overall team goals for GU

Requirements

BA degree or equivalent is required; MBA is preferred

5-7 years of relevant marketing brand management experience or equivalent (experience in oncology is preferred)

US Market Experience strongly preferred

Sales Experience Desirable

Strong written and verbal communication skills

Experience working with and leading multi-functional teams to accomplish specific objectives and goals

Experience in managing external resources and partners, including Advertising agencies

Experience in utilizing primary and secondary market research

Strong organization and prioritization skills

Strong ability to comprehend and discuss deep clinical data

Demonstrated strengths across BMS Behaviors

Summary

This position is for Sr. Specialty Retail Sales Representative located in Cleveland West.  

Sales candidates must be able to understand and apply knowledge of pertinent health care industry trends, sales trends, market dynamics, competitors, applicable laws and regulations, and health care payer environment, and analyze each of these factors in the development of actionable business plans and in daily execution of sales calls, within compliance guidelines.  Develop and implement territory plans that identify and prioritize activities and resources to accomplish short and long-term sales and business goals. 

An accountable self-starter who can develop deep customer insights, build and maintain strong professional relationships with physicians (primary care and specialists), pharmacists, nurses, office staff and other health care providers in the patient care continuum.  Appropriately leverage resources and apply sound account management skills and perseverance to secure customer access and maximize selling time.  Utilize deep understanding of disease states, BMS products, and as appropriate, relevant competitor products to tailor interactions with specific customers.  Excellent communication skills- verbal and written- including the ability to present to groups.

Collaborate across the Cardiovascular sales organization, CV Institutional Sales Representatives, cross functional teams and where appropriate alliance partners.   Work within matrix team to identify opportunities and develop appropriate tactics and strategies. Drive market share growth and maximize sales performance within the indicated use and approved patient types.

Possess a high level of ethics and integrity.  Adhere to all applicable laws, regulations, and BMS policies.

Requirements

Bachelor's degree or equivalent is required.  Minimum of 5 years of sales experience is preferred.  Demonstrated success in medical profession is advantageous.

A strong customer focus and analytical skills to identify and prioritize business opportunities is required.  Proven track record in delivering results and developing innovative approaches in evolving markets.  Previous new product or concept launch experience desired.  Ability to learn, apply, and grow disease state knowledge is  required.  Ability to effectively communicate technical and scientific product and disease information to a variety of customers in multiple settings.  Technical aptitude to learn and apply new technologies to manage a territory is required. 

Management retains the right to change the job specifications (may include grade level and salary range) and provisions of this job as appropriate.  In addition, we reserve the right to place candidates in positions at levels commensurate with their depth of knowledge around the following competencies:  Product and Disease State Knowledge, Market and Industry Knowledge, Sales Resource Utilization, Selling Skills, and Business Planning.

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. 

This is a critical role in the Pharma MS&T (Manufacturing Science & Technology) team.  The candidate will drive activities which actively measure robustness and reduce risk to our ongoing process and to the commercial supply of BMS pharma products.  This person will set and drive the expectations for product robustness both for new product launch from development and for existing products in manufacturing.  Accountability for the development of integrated strategies leveraging and incorporating input from our key stakeholders and partners, including the wider MS&T organization.

• Develop and implement structures, tools, and process to actively manage process performance/robustness across the portfolio.
• Lead activities to define, develop and implement best practices for active supply risk reduction across the commercially manufactured pharma portfolio.
• Drive the product robustness strategies for the BMS pharma portfolio and ensure that new pharma products are launched with an appropriate level of robustness.
• Assure that robustness monitoring and improvement programs are in place to proactively and continuously reduce risks associated with process performance, while improving process capabilities across the portfolio.
• Partner across the MS&T team, and in particular with pharma drug product and API development-to-launch leaders to drive appropriate levels of robustness into new product development projects.
• Define and set metrics, and regularly review product performance against these metrics with manufacturing and key stakeholders across BMS pharma portfolio.
• Ensure that an active roster of risk prioritized robustness improvement projects is maintained for the pharma product portfolio.
• Support, drive and influence a culture of product robustness within MS&T, into product development and throughout BMS.  Maintain subject matter expertise, awareness and influence of industry trends and best practices.
• Conduct training of best practices to drug product and A&I SMEs

Education:

• Minimum bachelors of science/engineering in a pharmaceutically relevant science or engineering discipline.  Advanced degree (MS/M Eng/PhD) strongly preferred.

Experience/Knowledge Desired:

• Minimum 12 years work experience in different roles across the pharma industry related to product robustness in development and manufacturing.  Or, minimum 6 years of experience with Ph.D. in a related field
• Strong awareness of methodologies pertinent to the function and be able to introduce them with limited supervisory input.
• Strong statistical and analytical skills are desirable
• Strong communication skills, including the ability to present to Sr. Management and global health authorities.
• Strong knowledge of health authority guidelines, expectations and best practices around product robustness, QdB principles, and validation.
• Demonstrated experience in building relationships and using influence.  Can establish credibility and earns respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managers. Is able to “get things done” without compromising principles.  A high level of energy and strong work ethic is critical to success.
• Excellent interpersonal, collaborative, team building, and communication skills to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset.

Major Duties:

This is a critical role in the Pharma MS&T (Manufacturing Science & Technology) team.  They will support all implemented process analytical technologies including RTRt (Real-Time Release testing) both internally and at our contract manufacturers.  This person will lead trouble shooting and investigations concerning PAT implementations.  In addition, they will support the development of directives and help drive standards including model maintenance activities that ensure the robust and beneficial application of PAT in manufacturing.

• Lead and support the transfer of process analytical methods and instruments between manufacturing sites and from development to manufacturing.
• Work with quality and regulatory leads to assure compliance and efficient use of process analytical technologies in manufacturing.
• Quickly resolve challenges at CMOs and internal manufacturing sites related to offline NIR tablet release testing and in-process monitoring and control.
• Lead and support model maintenance and method redevelopment as needed.
• Work closely and leverage PAT SMEs in the pharmaceutical development organization to help solve PAT issues, support model maintenance, and redevelop deployed methods. 
• Develop strategies and expectations (with respect to quality, regulatory, implementation, and purpose) for continued use of PAT in manufacturing
• Evaluate the commercial technical support requirements for PAT methods deployed in the manufacturing network.
• Ensure that programs are in place for PAT model maintenance, including instrument and method trend analysis and ensure they are consistent between manufacturing sites.
• Work with SMEs in each manufacturing location to support training, understanding and drive robustness of their PAT applications.
• Work with our PAT vendors to standardize instruments and vendor support throughout our manufacturing network.
• Lead activities to define, develop and implement best practices for PAT implementation across commercially manufactured pharma portfolio.
• Partner across the MS&T team, and in particular with pharma drug product and API development-to-launch leaders to drive expectations and objectives for including RTA into new product development projects.

Education:

• Minimum bachelors of science/engineering in a pharmaceutically relevant science or engineering discipline.  Advanced degree (MS/M Eng/PhD) strongly preferred.

Experience/Knowledge Desired:

• Minimum 8 years work experience in different roles across the pharma industry, or minimum of 3 years with a Ph.D. in a related field.
• Development of in-process analytical methods for monitoring and/or control
• OSD unit-operations understanding as it relates to in-process measurements
• Strong analytical and measurements background.  Competent in statistical analysis techniques required to understand method and process performance.
• Understanding and experience using chemometrics and analytical method development principles, including, PLS, PCA, PCR, etc.
• Understanding of FDA and EMA regulatory guidelines concerning PAT and chemometric model development, validation and implementation.
• Implementation of in-process and at-line measurements in manufacturing
• Health authority and quality understanding as it relates to PAT implementation
• Strong awareness of methodologies pertinent to the process analytical technologies and be able to introduce them with some supervisory input.
• Strong statistical and analytical skills are desirable
• Strong communication skills, including the ability to present to Sr. Management and global health authorities.
• Demonstrated experience in building relationships and using influence.  Can establish credibility and earns respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managers. Is able to “get things done” without compromising principles.  A high level of energy and strong work ethic is critical to success.
• Excellent interpersonal, collaborative, team building, and communication skills to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset.

The Integrated Technical Strategy (ITS) team in Manufacturing, Science and Technology (MS&T), is responsible for providing leadership and direction to the technical teams focused on the development, manufacturing and process lifecycle management of the BMS commercial pipeline.  
 
The Technical Product Team (TPT) Leader is accountable for leading an interdisciplinary technical team of scientists and engineers to develop, manage, and execute a complete CMC strategy for BMS biologics commercial products. The TPT Leader will manage one or more biologic commercial products depending upon their degree of technical complexity and workload demands.  The TPT Leader is a key member of the Global Operations (GO) Team and is responsible to develop and deliver on the CMC strategy while ensuring that the strategy aligns with the overall brand and GPS functional strategies. The TPT success will be measured by maintaining supply continuity, meeting customer service targets, successfully achieving regulatory approval of the technical agenda elements, and achieving process robustness milestones. The TPT Leader will also work closely with various internal governance committees to agree upon project prioritization and resulting timelines to assure that the technical teams are resourced to meet their objectives. This position can sit in either our Devens, MA site or our New Brunswick, NJ site.

Additional responsibilities include:

• TPT leader will work with the functional leads in MS&T (Drug Substance, Drug Product, Analytical, etc.) to create an integrated technical product roadmap, which details out the major projects/process improvements required to support the product’s lifecycle plan.
• TPT leader will partner with project manager to develop full project schedules, budgets, and resourcing for the activities listed on the technical product roadmap.
• TPT leader will actively participate in the Expanded Change Review Board (ECRB) to ensure product quality, compliance and supply requirements are met.
• TPTL leader will develop continuous improvement initiatives to help improve the overall efficiency and effectiveness for the management of our commercial product pipeline and deliver on process robustness priorities.
• TPT leader will manage and track the completion of all health authority commitments.
• TPT will provide a dedicated forum for issue resolution and active management of the product risk register, including developing the appropriate business continuity plans.

Qualifications/Experiences

• Bachelor or advanced degree in a life science, engineering or other technical discipline. 
• Over 10 years of technical experience in the commercial manufacturing of biologics drug substance and/or drug product.
• Direct experience in participating on and leading technical project teams in a highly matrixed environment. 
• Knowledge of CMC regulatory and analytical testing requirements is strongly preferred. 
• Ability to effectively utilize project management and Lean Six Sigma tools is a plus. 
• A developed business acumen and advanced quantitative analysis skills highly beneficial.
• Excellent interpersonal, collaborative, team building and communication skills. 
• Approximately 10-20% travel will be required between BMS sites (Devens, Syracuse, New Brunswick).

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 Associate Research Scientist will join the Integrated Oncology Discovery Research team at Bristol-Myers Squibb in Redwood City, CA to enable identification and advancement of early stage therapeutic targets at the intersection of tumor genetics and tumor immunobiology.

The qualified candidate is a highly motivated, interactive, and creative individual that possesses the ability to support early stage drug discovery programs by preclinical model development and target validation. The candidate will be expected to effectively collaborate with colleagues in the oncology, immunology and bioinformatics groups. The successful candidate will demonstrate clear understanding of principals of target identification, professional verbal and written communication skills, capable of presenting scientific results to multidisciplinary teams and key stakeholders.
The primary responsibilities for this role include target validation by engineering isogenic cell lines and characterization of downstream molecular pathways

Qualifications

• A B.S. with a minimum of 5 years of experience, or an M.S. with a minimum of 1+ years of academic/industrial experience with a strong scientific knowledge and research experience in cancer/cellular biology.
• Independence in experiment design, troubleshooting, data interpretation and literature search are required.
• Molecular biology skills, DNA cloning/purification, restriction, PCR, primer design, preparation of amplicons for sequencing are required.
• Good knowledge in cell engineering technologies, siRNA/shRNA and CRISPR based gene silencing; lentivirus generation and transduction are required.
• Knowledge of in-vitro cellular and biochemical assays (CTG, ELISA, Western blot) is required
• Experience with multicolor flow cytometry is desired
• Knowledge of signaling pathways, cancer genetics, syngeneic and genetically engineered mouse models is desired.
• 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.
• Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required.

This position is located in Redwood City, CA. There will be less than 10% travel.

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.

This is a critical role in the Technical Outsourcing Management team to maintain key vendor relationships, provide technical integration for outsourced methods and assure projects are completed within established specifications and timelines.

• Maintain key CRO partner relationships including contract and vendor management, facilitating good communication via teleconferences and on-line collaborative tools.
• Provide technical guidance on transferring LBA and Nab methods to CROs assuring that processes follow established best practices and meet regulatory requirements.
• Assist with troubleshooting technical issues at CROs.
• Provide execution leadership to give operational support for key programs to assure all bioanalytical data and reports meet specifications and timelines for database locks and filings.
• Identify and help resolve sample discrepancies and maintain data lock timelines.
• Work closely with key stakeholders across multiple departments to assure deliverables meet timelines and regulatory requirements.

• PhD with 5-10 years or MS/BS with >12 years’ experience in a relevant analytical scientific discipline (exceptional candidate with lower experience level will be considered)
• Experience with various bioanalytical technologies for biologics, such as ELISA, MSD, Gyros for PK, ADA and cell-based Nab
• Familiarity with regulatory guidance and industry practices for bioanalysis and immunogenicity
• Good knowledge of drug development process
• Understanding of regulatory requirement for bioanalytical data reporting
• Excellent interpersonal, organization and communication skills
• Ability to work effectively in cross-functional teams
• Experience in managing CROs
• Ability to work efficiently on multiple tasks in a fast-paced team environment

Bristol-Myers Squibb is actively conducting translational medicine research to further our understanding of cancer biology and to identify which patient populations may be more likely to derive benefit from Immuno-Oncology (I-O).  Bristol-Myers Squibb has long believed the future of cancer research is dependent on investments in science and partnerships. Collaboration is integrated into our organizational framework across Translational Medicine and R&D. 

The Clinical Biomarker Scientist (Director) is responsible for developing and executing on translational strategies for the Oncology pipeline. This scientist works on various projects in either early or late drug development and will act as a key interface with the Translational Medicine Team Lead.

Responsibilities:

•    Responsible for integrating translational research and clinical development, development a biomarker strategy in alignment with clinical development objectives, leading efforts for data generations, interpretation and communication to the development teams.

•    Responsible for understanding external research environment, partnering with Discovery biology and other functions both internally and externally to coordinate the execution of Translational Medicine deliverables.

•    Engages functional groups to develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals.

•    Effectively engages with teams and matrix leadership to define, revise and progress translational/biomarker plans.

•    Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving towards delivering key data and interpretation essential for decision making.

•    Delivers high quality biomarker strategies for target engagement, pharmacodynamics endpoints and patient selection

•    Ensures the output of the biomarker plans meets established project standards.

•    Engages team members to ensure alignment of biomarker strategies with clinical operational plans with functional area capabilities

•    Builds productive relationships with team members that interact with the clinical biomarker group.

•    Effectively interfaces with functional areas to ensure strategic alignment and to identify resources needed to deliver on biomarker goals.

•    Communicates key biomarker program information, risks, and milestones, and manages information flow across team members.

Qualifications:

•    MD, PhD, or equivalent advanced biology degree strongly preferred.

•    Experienced scientist with 5+ years of experience in the drug development process.

•    Significant understanding of the role of translational research/medicine and clinical biomarkers in drug development

•    Demonstrated knowledge of oncology and/or tumor-immunology disease biology

The Quality Optimization Lead, Internal Sites (QOL) position supports the Head of Internal Sites Quality on the operations management and is responsible to (i) to be the primary point of a contact for Internal Sites on the MSQ Network Quality and/or Network QC strategy execution elements and provides strategic input to ensure projects enable value to be delivered as planned. (ii) advance and harmonize the Quality/ Compliance Excellence and other continuous improvement strategies across the internal sites of the network as per objectives. (iii) ensures appropriate transparency exists to drive Quality Operations Excellence for Internal Sites (iv) provides Quality Leadership for Network Optimization efforts, involving current or future internal assets in Bio & Pharma.

This position will be the primary delegate of the Head of ISQ, is based in New Brunswick and requires ~25% travel

Duties

• Establish, report and run the Internal Sites Quality Operations Monthly Review to ensure the proper transparency and escalation of Internal Sites Quality Operations, Compliance Performance, Network QA and Network QC Projects occurs.
• Monitor quality and compliance for internal sites, through the established quality metrics and ensures there is continued alignment with BMS Tiered Quality Council Governance model, Global Quality Performance Management Organization and Operations Management Organization in the establishment, revision, reporting of metrics and/or escalation of issues.
• Support the Head of Internal Sites Quality, in the generation of any required Tier 2 Quality Council data analysis, escalation or reporting, ensuring integration and collaboration with other areas across Global Quality.
• Provide leadership and influence a dynamic and diverse staff of Quality professionals across the network, to ensure the sites develop, plan and monitor Quality/ Compliance Excellence, and continuous improvement strategies as per objectives.
• Lead at the above site level QC and QA operational excellence initiatives of internal sites to ensure transformational changes occur to drive Quality Operations competitive advantage.
• Support best practices sharing /knowledge management across the network including linkages to EXM, provide a space for external focus, and support bringing in market practices/benchmark.
• Act as a single point of contact for Internal Sites with the Network Quality Lead and the Network QC Lead.  In this capacity, liaise with the Network Quality and Network QC Lead to understand all network quality strategic projects affecting the sites and ensures these projects are properly communicated, planned, chartered and executed at the site level.
• Provide Quality Leadership for GPS Network Optimization efforts, involving current or future internal assets in Bio & Pharma, in conjunction with the Head of Internal Sites Quality and in collaboration with other stakeholders.
• In providing Quality Leadership, collaborate with other members of the MSQ and across GQ organization and seek concurrence while dealing with complex issues.  Use critical analysis and develop ethical, risk-based solutions to meet both business and regulatory requirements.
• Coordinates and/or provides SME input to for BMS Policies, Directives, SOPs related to quality compliance when required.
• Leads communication and develops effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations.

Education

Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferred.

Experience / Knowledge

• Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
• Mastery of Quality compliance processes and regulations, e.g., cGMP/GDP regulations.
• A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
• Familiar with electronic quality systems tools
• A minimum of 10 years of experience in quality operations
• A minimum of 15 years of experience in pharmaceutical operations

Skills and Competences

• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization. 
• Strategic thinker who sees the bigger picture and possesses  high business acumen; understands how the parts impact the whole (end to end enterprise)  and makes the best decisions for the whole
• Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on Head of Quality for Internal Sites behalf and interface with stakeholders in a matrix environment. 
• Uses judgment to make sound decisions based on information gathered and analyzed.
• Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures. 
• Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
• Has a proven track record of delivering results and is action oriented.
• Completes work in a timely and consistent manner.
• Adapts to changing work environments, work priorities and organizational needs.
• Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.
• Organizes and delivers information appropriately.

Provide strong Technical / Solution Architecture leadership across a team of strong scientifically oriented application developers comprised of BMS staff, onshore and offshore contractors.  Will be responsible for establishing overall application solution architecture patterns (generally), defining specific project-level solution architectures, and either individually and-or as leader of project team implement the solution.  The successful candidate will be a seasoned solution architect with hands-on experience across a wide range of current IT technologies.

Position Requirements

• BS in Computer Science or related degree required.   Masters in Computer Science or a related field preferred.  8+ years relevant experience, including:

• Delivery-focused application development environment, including design and delivery of robust, scalable and performant web services.

• Full life cycle implementation of applications and services: requirement gathering, design, development, test, implementation and support.

• API and resource-representation design for backwards and forwards compatibility.

• Specific technical knowledge desired: credible experience with core technologies including .Net 4.0, ASP.NET MVC3, WCF, AQS (or similar), no-SQL databases, Windows, IIS, architecture for server farms, Linux, Oracle, Java.

• Track record of managing a portfolio of development projects, successfully balancing priorities, resolving issues, and communicating status.

• Ability to contribute to strategic direction and to convert strategy to execution, including driving a strong service-oriented architectural strategy.

• High energy, strategic thinking and superior oral and written communications skills are required, including the ability to communicate effectively with scientific clients, technology specialists, and managers.

• Experience developing systems for a research environment is desirable but not essential.

• Model the BMS core behaviors: decide and act, connect and collaborate, innovate and improve, grow and engage.

• Domain includes a wide-range of in-house developed scientifically-oriented applications supporting BMS Research activities
• Integration of COTS solutions into Research IT portfolio
• Become the "go to" architect for team's most challenging technical challenges.
• Be a coder
• Create and maintain effective relationship with Enterprise Architectural community
• Reports to Head (Director), Research Architecture & Platforms