Career Category
Medical AffairsJob Description
The regional senior medical advisor will be responsible for acute leukemia product and pipelines. Through cross-functional collaboration and deep understanding of the treatment landscape, the senior medical advisor will work closely with regional and country team to support the development of the JAPAC regional product and medical strategy and plan.
Responsibilities
Partner with Development team to accelerate innovative pipeline by providing regional strategic input on treatment landscape, registrational and product life cycle management programs for acute leukemia pipeline
Support development of the JAPAC medical strategy and working plan for acute leukemia pipeline products
Developing and executing of regional product medical strategy, via the Regional Medical Plan, including pre-launch activities, launch support and lifecycle management, in collaboration with Product Team/Portfolio
Defining regional scientific evidence gaps and supporting to development of local evidence generation strategy
Engagement strategy and execution with medical experts, professional societies, patient groups and other key stakeholders
Participating in development of data communication strategy (including congress and other educational activities)
Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
Supports implementation of Medical governance for respective products, which includes:
Safety and pharmacovigilance as a key and effective partner with GRAAS
Clinical trial conduct
Risk management/minimization in collaboration with GRAAS
Subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)
Medical / Scientific contribution to Value Dossiers, compendia and interactions with payers in collaboration with VA&P
Ensures appropriate medical leadership of compliance; accountable for the conduct of medical activities for acute leukemia disease area according to all relevant compliance standards, regulations and SOP`s; Role models appropriate and compliant behaviors and contributes to creating a climate of compliance adherence across the organization
Basic Qualifications
MD degree from an accredited medical school OR PhD OR PharmD
AND
6-8 years of Medical Affairs and development experience in Malignant Hematology
AND
Clinical and disease knowledge base in hematological malignancies
Preferred Qualifications
MD plus accredited fellowship in Hematology-Oncology, board certified or board eligible
5+ years of Medical Affairs experience in the pharma/biotech industry
Hematology therapeutic area expertise (focus on hematologic malignancies)
Clinical research/development/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
Experience with clinical study and translational research support and conduct within Hematology (industry or academic clinical research)
Experience with opinion leader interactions, publications planning, data generation activities and medical accuracy review
Experience with integrated delivery networks, accountable care organizations, and payers
Experience in a matrix environment
We are one of the world’s leading biotechnology companies, with a particular focus on cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. And we put much of our success discovering and producing medicines and therapies down to our biology first approach.
In short, this is a place for innovation. Where ideas are not just welcome, but celebrated. Where you will have a peer group of 20,000 inspirational colleagues, not to mention the resources only a $20bn+ business can provide. This is your chance to make a positive impact on the world.
We are an Equal Opportunity employer. We appreciate, nurture and celebrate talent, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran or disability status.
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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