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.

• Deliver I-O treatment message to oncologists and pathologists

• Carry out quality control program to improve lung cancer tissue IO treatment diagnosis

• Collaborate with cross functional team in field to ensure testing availability and testing journey management

• Gather insights and inputs on testing, and gain a full understanding of customer needs and behaviors, as well as scientific activities within Oncology

• Giving input for diagnose strategy development

• Support MDT platform establishment within hospitals

• Prepare Bio-marker training materials and provide testing training to sales, COE, KA etc.

• Under global and medical biomarker guidance, prepare for future potential IO biomarker exploration and clinical practice enhancement in China

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.

Celgene, a wholly owned subsidiary of Bristol-Myers Squibb is looking for a Medical Affairs Advisor to join the UK Cellular Therapy team.

Purpose

Under the direction of the Associate Director of Medical Affairs Cellular Therapy, this position is responsible for leading, tactically developing and delivering a full range of Medical Affairs activities undertaken in the UK & Ireland affiliate.

The successful candidate will have already gained a good working knowledge and be able to provide examples of best practice in Medical Affairs. They will demonstrate the ability to take responsibility for delivering key medical affairs activities; including but not be limited to running advisory boards, producing medical materials and medical education initiatives, delivering training, scientific symposia, publication work, maintaining a network of medical thought leaders and taking a leading collaborative role in delivering health technology assessment submissions. In addition, it is preferable that the candidate has a track record as a final medical signatory for longer than 12 months.

The successful candidate will be medical practitioner or pharmacist registered in the UK. They will be looking to expand their current industry experience in a Medical Affairs role working in the exciting and evolving field of cellular therapies.

He / she will provide technical/scientific consultation to both the medical, market access and commercial teams, ensuring accuracy and compliance with the Celgene standards and UK / Ireland rules and regulations. They will have a have a strong scientific / medical background and be able to converse all levels.

Role and Responsibilities

• Provide support to the Associate Director Medical Affairs Cellular Therapy in developing and implementing Medical Affairs’ initiatives to support the needs of the affiliate including but not limited to:
  • Organisation and running of medical education meetings & initiatives
  • Running advisory boards
  • Collection & analysis of real-world evidence (where required)
  • Publication review & delivery
  • Medical training and clinical updates

• Develop & deliver HTA submissions working in partnership with market access colleagues where required
• Develop and maintain excellent thought leader relationships in conjunction with broader franchise team
• Work collaboratively and provides scientific support to Marketing, Regulatory, Market Access, Pharmacovigilance & the wider Disease Team.
• An active member in the UK & Ireland Cellular Therapy disease team able to:
  • Take accountability for the development, oversight and execution of the strategic medical plan in partnership with the Associate Director Medical Affairs Cellular Therapy  
  • Provide medical input into strategic positioning, differentiation and key marketing messages for brands
  • Work in partnership with Marketing to develop high quality briefing, promotional and core claim materials
  • Contribute & provide input into strategic (3 year) and operational (1 year) plans
• Supports Medical Information enquiry handling process and advise on medical safety or clinical issues as required
• Able to apply good working knowledge of ABPI/IPHA Codes of Practice and Celgene Standard Operating Procedures (SOP) and can advise on compliance issues and review promotional materials and activities to ensure compliance with ABPI Code of Practice regulations
• Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards
• Provide strategic input into the development and execution of clinical trials, IIT activities and publication plans
• Ensure adverse events and pregnancy reports are duly processed in line with company procedures and assist in assessment of adverse event reports originating in the UK and Ireland for completeness, consistency and reporting requirements
• Regularly review clinical articles relating to therapeutic area and attend update events such as scientific meetings, conferences/symposia to maintain therapy area knowledge ensuring good quality feedback to relevant colleagues

Skills and Knowledge Requirements:

• Medically qualified GMC registered Physician or Pharmacist with UK registration
• Medical Affairs experience from the pharmaceutical sector
• Final signatory experience, preferred
• Ideally relevant therapeutic area experience in haematology or oncology is preferred
• If a Healthcare professional , 2-4 years’ clinical experience, preferably within the NHS
• Organisational, problem solving & collaborate cross functional working skills 
• Customer focus & timely results orientation approach
• The ability to communicate complex and challenging issues and data to wide range of professional and lay audiences, adapting message and style to suit
• Excellent interpersonal & team working skills
• Project and time management skills
• IT aptitude
• Sociable, confident and outgoing

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.

MSM embody our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimise medical practice and drive appropriate adoption of BMS medicines. The MSM role is a field-based role. It is anticipated that a MSM/L will spend a minimum of 60-70% of their time in the field with external customers.

Position summary:

The primary role of MSM/Ls is to develop and maintain contacts with Thought Leaders (TL) and Healthcare Providers (HCP) within their healthcare system. The purpose of interactions is to ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer to peer discussions aligned with medical strategies and needs expressed by the stakeholders. The scientific dialogue focuses on scientific/clinical information around disease management and BMS products in a fair and balanced way and includes appropriate Health Economics and Outcomes Research (HEOR) data.

Position responsibilities:

1.      External Environment and Customer Focus

• Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSM/Ls will use various channels for interactions (1:1, group presentation; remote, etc).

• Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives.

• Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers.

• Collect and provide meaningful medical insights back to the medical and commercial organisations to be actioned in support of the strategy development.

2.      Contribute to the Medical Plan

• Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs.

• Adopt institution/account planning approach and contribute to cross-functional institution/account plans.

• Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan.

3.      Provide Medical Support

• As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access).

• Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers.

4.      Support Clinical Trial Activities

• Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document.

• Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management.

• Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document.

• Support HCPs in the ISR submission process as agreed with local medical management.

• Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events.

Requirements:

·         MD, PharmD or PhD, with experience in a specific Disease Area or with a broad medical background (preferred) OR Science Graduate with relevant pharmaceutical experience.

·         Experience in working in a scientific and/or clinical research environment.

·         Ability to work independently and act as a team player.

·         Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients.

·         Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals.

·         Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals

·         Ability to quickly and comprehensively learn about new subject areas and environments.

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.

Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team.

For our Team in Boudry and to work closely with our USA Colleagues, you would be mainly responsible for

• Implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
• Successfully leading plans, and executing trial level activities for multiple trials with minimal to moderate level of supervision
• Providing scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
• Co-Leading study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
• Maintaining a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Planning and leading the implementation all study startup/conduct/close-out activities as applicable
• Evaluating innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
• Site-facing activities such as training and serving as primary contact for clinical questions
• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
• Clinical data trend identification; provide trends and escalate questions to Medical Monitor
• Developing clinical narrative plan; reviewing clinical narratives
• Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
• Reviewing development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
• Drafting/reviewing and validating clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
• Collaborate and serve as primary liaison between external partners for scientific advice

Your Profile:

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
• 5+ years of experience in clinical science, clinical research, or equivalent
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Excellent verbal, written, communication and interpersonal skills in Englis
• Ability to assimilate technical information quickly
• You are detail-oriented and have a strong sense of teamwork; ability to lead team activities
• Proficient in Medical Terminology and medical writing skills
• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
• Proficient critical thinking, problem solving, decision making skills

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

Biometrics and Data Science, MAMA & Pediatrics, Boudry

PREREQUISITES

MSc or Ph.D. student in (Bio‐) Statistics. Experienced in SAS and/or R and/or Python

Description of the project and work required (including references)

The analyses of adverse events (AEs) plays an important role in the regulatory process of drug approval, as well as in the benefit assessment of drugs after approval. In case of varying follow‐up times, methods based on survival time analyses are preferred compared with analyses based on contingency tables. In this setting, competing risks models are recommended for the estimation of the cumulative incidence functions1,2.

Methods for the estimation of the cumulative incidence function and for studying the covariate effects on the cumulative incidence function are available. One of the standard approaches is to model cause‐specific hazards for all causes using the Cox proportional hazards model (or other semiparametric models, or parametric models e.g Weibull, lognormal models). Another method is the Fine‐Gray model that directly assesses the effect of covariates on the sub‐distribution function. Confusion still exists as to how choose amongst available methods and how to interpret effect estimates. A new approach to competing risks is using random forests that is a fully non‐parametric method and can be used for selecting event‐specific variables and for estimating the cumulative incidence function.

However, those methods have not used a formal framework for characterizing causal effects. In this proposed project the aim is to explore methods for accounting for potential confounding in competing risk settings, in the causal framework, the parametric g‐formula and IPW estimators will be used to estimate the risk of the competing event and the corresponding total treatment effects.

To make the approach robust to model‐misspecification, we will attempt to use Superlearner, an ensemble of methods.

The above methods will be applied to study PASS‐001, an observational post authorization safety study with primary endpoint characterize and determine the incidence of adverse events of special interest. The study includes 2150 subjects in the Lenalidomide cohort and 1479 in the Background cohort. It would be of great value to make an exhaustive analysis on the most important adverse events using competing risk methodology.