Medical Advisor/Disease Area Specialist (DAS) CAR-T

Medical Advisor/Disease Area Specialist (DAS) CAR-T

BMS - Bristol-Myers Squibb

Braine L'Alleud, Belgium

Position Summary/Objective

The objective of the Disease Area Specialist position is to serve as a product / brand reference point; to contribute to brand plans and strategies; to contribute and review materials; to identify, plan and manage the involvement of the country in clinical trials; to lead analysis and publication of local clinical trials; to contribute to customer focused activities and serve as expert contributor to internal stakeholders.

Position Responsibilities - Expected Areas of Competence

The position is required to perform 10 Core Roles and 2 Supplementary Roles.

Core Roles

Product/Brand Reference Point:

  • Continuously update knowledge of products, patient treatment trends and scientific activities within the Disease Area;
  • Ensure timely and informative responses to scientific queries from external customers and internal partners, which accurately reflect scientific data;
  • Act as a champion for the medical benefits of a product or products, and as the first point of contact for GDO.

Clinical Trial Identification & Planning:

  • Develop the local medical plan;
  • Design and initiate local trials that meet scientific needs, and take into account regulatory and legal requirements, and, where appropriate, business needs;
  • Ensure local clinical activities go through internal and external approval processes;
  • Provide significant medical input on trial and survey feasibility and site suitability;
  • Work with GDO to review protocols, set local recruitment targets and select sites.

Clinical Trial Manager:

  • Take joint responsibility for patient recruitment for local and GDO studies with the Site Manager;
  • Support the Site Manager and Site Monitors on medical activities related to the delivery of a trial or survey;
  • Monitor progress of local trials, ensure they are properly conducted and meet planned timelines.

Local Clinical Trial Analysis and Publications:

  • Support statisticians with the analysis of local trials by providing medical insight;
  • Review and provide input on analysis plan for local trials;
  • Prepare presentational materials, that accurately and fully reflect research outcomes and contribute to developing brand strategies that meet patient needs;
  • Review and provide input to Final Study Report (FSR) and related publications and obtain internal approval;
  • Ensure that investigators, and other partners in the conduct of a trial, have access to the results before public communication.

Pharmacovigilance:

  • Ensure understanding of BMS Pharmacovigilance SOP’s;
  • Help manage the customer appropriately when SAEs and unexpected AEs arise, with the wellbeing of patients the ultimate goal;
  • Contribute to ensuring the high standards of clinical safety.

Contributor to Brand Plans & Strategies:

  • Participate as a member of the Local Brand Team through developing the Local Medical Plan and contributing to and challenging other aspects of the Local Brand Plan to ensure brand strategy always serves patient needs;
  • Build effective partnerships with Marketing counterparts;
  • Leverage medical insight from External Experts and other customers and knowledge of recent scientific publications to contribute to the development of Brand Plans and Strategies.

Promotional Material Contributor & Reviewer:

  • Assess promotional materials to ensure that all claims are fully supported by scientific data, and are presented in an accurate, fair and balanced manner;
  • Contribute to the scientific content of promotional material, drawing on relevant scientific data and External Expert insights;
  • Assess promotional material in line with the appropriate SOP, clearly express rationale for any objections and sign off before release.

Contributor to Customer Focused Activity:

  • Contribute to building high value-added medical programs such as Continuous Medical Educational Programs and Symposia;
  • Prepare BMS speakers for BMS symposia;
  • Contribute to development of scientific publications.

Expert Contributor to Internal Customers (Marketing, Regulatory, OR, PV, Legal Counsel):

  • Provide scientific support to Marketing, Regulatory, Outcomes Research, Pharmacovigilance and Legal Counsel;
  • Contribute to the clinical development sections of OR reports;
  • Provide medical insight for OR studies and advice on how to conduct trials;
  • Communicate closely with the Regulatory group;
  • Assist Legal in describing the medical basis for promotional materials, in the event of challenge by another party.

Support & Trainer:

  • Ensure the Sales Force receive appropriate medical training -- in collaboration with the training department -- enabling them to understand and convey the scientific benefits of a Brand appropriately;
  • Review training documents to check medical accuracy and compliance with regulatory requirements;
  • Ensure Site Managers and Monitors are trained in BMS products, medical concepts and available therapies.

Secondary Roles

External Expert Manager:

  • Maintain direct contact with External Experts to gather insights and input on treatments, and gain a full understanding of patient needs and behaviours, as well as scientific activities within the Disease Area;
  • Involve External Experts in local studies and other scientific activities.

Compliance:

  • Develop an understanding of SOPs, GCP and ICH, as well as legal and ethical standards;
  • Alert management to possible compliance issues.

Degree Requirements

  • Medical doctor (physician) with experience in a specific Disease Area or with a broad medical background is preferred and at least 5 years of experience of executive responsibilities in a multinational organization.

Experience Requirements

  • Designing and implementing clinical trials;
  • Developing and delivering presentations and publications in English and local language;
  • Training others.

Key Competency Requirements

  • Disease Area knowledge, including key scientific publications;
  • Understanding of product development process over different stages;
  • Basic statistical techniques.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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