Disease Area Specialist Gi/ Early Assets

il y a 2 semaines

Brainel'Alleud, Belgique Bristol Myers Squibb Temps plein

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**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 conce

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