US Medical Head, Amyloidosis

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

The US Medical, ATTR, plays a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The position will support US Medical – CVRM TA activities, with primary responsibility as the lead medical and scientific authority for Amyloidosis within US Medical’s Cardiovascular Renal Metabolic Therapeutic Area.

The US Medical, ATTR, will be instrumental in crafting and influencing strategic directions to guide internal and external decision-making. Major activities include strategic feedback and mentorship to Medical Action Plans, oversight of US-based studies and post-marketing surveillance; management of field medical teams; interface, educate, and gain insights from external partners, including government agencies, professional medical societies, mentorship committees, key opinion leaders and key decision makers on issues related to the AstraZeneca assets; collaborate with R&D, Commercial Operations, Global functions and many other internal partners in support of our assets; coordinate external authority advisory boards, scientific symposia, and CME programs; be responsible for Medical activities related to review of promotional and scientific materials.

What You'll Do:

• Lead Core Medical Teams (CMT)
• Accountable for the brand medical strategy and creation/delivery of brand medical plan
• Accountable for an appropriate development budget and resource requirements to support the development needs for the brand.
• Own the delivery of US-based evidence generation, including Clinical Trials, Real World Evidence Studies, Investigator Initiated and Sponsored Research, and Publications
• Proactively build and maintain internal and external relationships to further the progress of the business
• Lead development of the US Advisory Board strategy
• Represent US Medical on the GMT, incorporating US healthcare system perspectives and personal expertise
• Maintain a view of the competitive landscape and a broad perspective across AZ and the pharma industry to identify and drive standard methodology in support of healthcare innovation, working with external authorities, technology partners, and other collaborators to accelerate practice change efforts
• Regulatory Strategy: Experience in the development and approval of a product through the regulatory process; work with the development team in preparing FDA briefing documents, preparing for FDA meetings and participating in FDA meetings; review and strategy of developing NDA documentation; participate in and collaborate with both commercial and development in the labeling negotiations for a product approval.
• Global Interactions: Represent US Medical on Global Medical Teams, incorporating US healthcare system perspectives and personal expertise into both the Global and US Medical strategy and operational plans.
• Drug development experience, know and understand the nuances of pre-IND through Phase 3 drug development

Minimum Qualifications:

• Sophisticated Scientific Degree (MBBS, PharmD, PhD, or MD) or international equivalent
• A minimum of 7 years of experience in medical affairs-related medical/scientific activities, including research, clinical development, and epidemiological programs
• A minimum of 4 years of clinical experience in the US
• Expertise in cardiovascular renal diseases with a consistent track record to harmonize with senior authorities, influence and collaborate with peers, and oversee and guide the work of other colleagues to achieve significant outcomes and build business impact

Skills/Capabilities:

• Comprehensive understanding of pharmaceutical product planning, regulatory environment, marketing, and promotion
• Comprehensive understanding of the US healthcare environment
• Strong intuition for business, including proven understanding of the changing U.S. payer and provider landscape
• Proven track record in interacting efficiently with both commercial and scientific colleagues
• Demonstrated ability to work collaboratively in cross-functional teams
• Ability to travel nationally and internationally. Travel will be approximately 30% of the time