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Manager or Director, Medical Affairs, Benlysta
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Manager or Director, Medical Affairs, Benlysta : GlaxoSmithKline
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| Job Number |
73474 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Research Triangle Park
North-Carolina
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
1/31/2012 |
| Industry |
Pharmaceutical |
| Job Type |
Other |
| Relocation |
Not Required |
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| Description |
Basic Qualification
• Bachelor's degree required
• Medical affairs or other drug development experience required for Director level
• Experience demonstrating leadership and motivational skills, project management capabilities planning and organizational skills is required
• Experience applying scientific and analytical problem solving skills required
• Skill working in a matrix environment including influencing and collaboration, written and oral communications and diplomacy required to work well with alliance partners
Details
An exciting position is available for a seasoned professional to join the Benlysta Team at GSK. This senior role is part of the Medical Affairs group supporting the first FDA approved drug for the treatment of lupus systemic lupus erythematosus (SLE) in 50 years.
The Manager/Director Medical Affairs works closely with the Physician, Medical Affairs Lead (PMAL) to drive excellence, alignment and coordination of Global Medical Affairs support for Benlysta. The Manager/Director will work with physicians to assist with and may be responsible for the development and execution of the medical plan, including the oversight of clinical and outcomes trials, external medical relations, medical information and scientific communications for the brand.
The Manager/Director Medical Affairs duties include:
• Provide medical support for the life cycle of Benlysta (belimumab) and ensure alignment with brand strategy and life cycle plans
• Develop medical commercial strategy, input and approval of marketing copy, medical governance, input to study design, protocol writing and medical aspects of study conduct
• Responsible for interpreting clinical safety and efficacy data and supporting documentation for regulatory submissions
• Provide integrated project management support to the Benlysta Medical Affairs team to ensure alignment across objectives, adherence to project deliverable timelines and effective communications
• Provide clinical and project management support on global project team as representative or leader
• Actively contribute to the development of therapeutic area specific strategy for selected products or programs in the US and provide selected contributions to the global strategy
• Provide timely and clear communication to internal functional team members and to alliance partners
• Collaborate with alliance partners throughout clinical development life cycle of an asset
• Accountable for comprehensive study status reporting
• Help identify and troubleshoot potential issues regarding Phase I-IV studies to ensure internal approval with senior management and externally at Investigational Review Boards and Ethics Committees
• Ensure alignment and support of project by relevant GSK line functions at a senior level
• Ensure strategic objectives and proposed clinical studies have been captured within the Clinical Development Plan (CDP), the Integrated Project Plan (IPP), and the Benefit Risk Management Plan (BRMP)
• Accountable for relevant resources supporting clinical development activities and evaluation against timelines (assigned budgets, grants, etc.); oversees investigator agreements and key budgets
• Participate in the review, interpretation, and publication of clinical study results from Phase I-IV studies
• Actively seek external advice from global experts and from FDA/EMEA when appropriate
• Participate in Advisory Board meetings, speaker training, MSL training, Plan of Action training of the sales force and consultation to other asset teams
• Author clinical protocols with input from matrix team
• Present protocols at investigator meetings
• Interact with Drug Discovery colleagues in designing Proof of Concept studies and drafting post-PoC clinical development plans
• Participate in a global matrix team once compounds have progressed to Medicine Development |
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| Requirements |
Preferred Qualification
• Advanced scientific or medical degree strongly preferred; training as nurse clinician or physician’s assistant and clinical rheumatology experience very desirable
• Experience in rheumatology or autoimmune diseases and internal medicine and previous US Medical Affairs experience is strongly preferred; clinical experience in systemic lupus erythematosus (SLE) and autoimmune diseases preferred
• Skill working in a matrix environment including influencing and collaboration, written and oral communications and diplomacy required to work well with alliance partners |
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| Contact Info |
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