Medical and Regulatory Affairs
Bristol-Myers Squibb 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.
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Under the direction of the Associate Director of Medical Affairs Cellular Therapy, the Cellular Therapy Medical Specialist will:
Serve as a field based healthcare professional focused contact to facilitate cross-functional support to Cell therapy centres. Deliver high quality clinical & scientific knowledge & support to healthcare professionals in Cellular Therapy treatment, referring centres and Celgene colleagues
As part of a wider cross-functional team, the Cellular Therapy Medical Specialist will be responsible for working in partnership with Celgene commercial, patient operations and quality assurance teams, to onboard, activate and provide ongoing support to Cell Therapy delivery centres, enabling them to deliver Celgene Cell therapy products safely and efficiently. He/she will serve as a key point of contact for product, process and patient safety related questions at Cell therapy treatment sites, ensuring process consistency & compliance. He/she will be a trusted partner, valued for being a Cell therapy subject matter expert, able to deliver high quality clinical / scientific exchange and training alongside solving practical / logistical issues to ensure timely interventions at all stages of the patient treatment pathway.
The successful candidate will ideally have relevant therapeutic area experience in haematology or oncology. They will be looking to expand their current industry experience in the exciting and evolving field of cellular therapies. They will have a strong scientific / medical background and be able to converse at all levels.
Role and Responsibilities:
- Work in partnership with the Associate Director Medical Affairs Cellular therapy to develop and implement Medical initiatives enabling effective delivery of Cell therapies at treatment centres in the UK & Ireland
- As part of a cross functional team, partner, onboard and activate Cell therapy treatment sites, enabling them to deliver Celgene Cell therapy products effectively & safely
- Assess site clinical experience & capabilities to safely manage and deliver Cell therapy treatments
- Ensure quality management plans, standard operating procedures and treatment algorithms are in place to ensure patient safety
- Delivery of external training to appropriate personnel (Cell therapy care management teams) on delivering cell therapies within the commercial setting including product & risk management training
- Patient specific proactive and reactive follow up with site personnel (e.g. Cell therapy cell coordinators/nursing staff) post Cell therapy cell infusion
- Collaborate with commercial, patient operations, quality assurance, drug safety & risk management and clinical trial teams
- Responsible to ensure site level medical milestones are met on time and with high quality
- Develop and maintain excellent thought leader relationships in conjunction with broader franchise team
- Develop subject matter expertise in Cell Therapies & participate in initiatives to continuously improve processes involved in the delivery of Cellular therapy
- Responds to HCP requests for clinical / scientific information
- Work collaboratively and provide scientific support to Marketing, Regulatory, Market Access, Pharmacovigilance & the wider Disease Team.
- Works with IIT Manager and relevant disease teams to co-ordinate proposals for Investigator Initiated Trials (IITs)
- Development & delivery of Cell therapy scientific training to internal colleagues (where required)
- Provision of Cell therapy medical insight to relevant Celgene colleagues
- Contribute & provide input to the Cell therapy medical initiatives and the development of 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)
- Ensure compliance with SOPs, GCP, GMP and ICH as well as legal and ethical standards
- 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:
- Undergraduate degree in life sciences required. Advanced degree in the life sciences (e.g. MS, MSN, PhD, PharmD, NP, PA) preferred.
- Ability to assimilate technical and scientific information quickly with advanced scientific / medical writing skills
- Prior pharmaceutical industry and ideally clinical experience which includes direct communication with thought leaders, clinical investigators, site personnel
- Working knowledge of Haematology / Oncology, ideally in the fields of Stem Cell Transplantation, leukemia, lymphoma, and multiple myeloma
Detail orientated with excellent organisation & planning skills
Team player: Able to build strong networks and partnerships
Able to operate in a changing / fast moving environment
Leadership & problem-solving skills
- National Health Service
- Clinical trial design & principles
- GCP, ICH guidelines and the FACT / JACIE accreditation process
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.