AstraZeneca Pharmaceuticals LP Renal Cardio Medical Head in Wilmington, Delaware
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. As the Renal Cardio Medical Lead, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives.
The Renal Cardio Medical Lead is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical Team. The position can be either a Senior Director or Executive Director based upon the individual's experience. The Medical Lead is knowledgeable of the actions of regulatory bodies, in particular, knowledge of the FDA. He/She has experience in clinical trials both for registration as well as trials of the 3b/4 type to fill scientific gaps relative to an initial development program. An ideal candidate should have significant experience in renal and cardiovascular disease management and would thrive on proactively engaging internal and external leaders. S/he is accountable for the development and execution of the US Renal Cardio Medical Plan, and leadership of the Renal Cardio Core Medical teams. The ideal Medical Lead would have a network of nephrology external scientific expert and Professional Society relationships. As a member of the Global Product Team, the Medical Lead represents the US on the Global Product Team for life cycle management, labeling, and other externally sponsored research.
Co-lead the Renal Cardio Brand team with the Commercial Brand Leader
Lead Renal Cardio Core Medical Teams (CMT)
Accountable for the brand medical strategy and creation and delivery of brand medical plan
Accountable for an appropriate development budget and resource requirements to support the development needs for the brand.
Lead the delivery of U.S.-based clinical development activities, including Clinical Trials, Real World Evidence Studies, Investigator Initiated and Sponsored Research, and Publications
Manage and develop direct reports and deployed resources including brand Medical Directors, Field Physicians, and Directors of Medical Alignment (as appropriate)
Create an atmosphere of clear accountabilities.
Ensure compliance with all AZ corporate policies
As part of Medical Plan, ensure comprehensive engagement plan with customers and key stakeholders, e.g., Managed Care Organizations, Key Opinion Leaders, Key Institutions and Hospital Systems, Professional Societies
Develop and maintain relationships with key external and internal customers.
Lead development of an Advisory Board strategy
Represent US Medical Affairs on the Renal Cardio Global Product Team, GMT incorporating US healthcare system perspectives and personal expertise
Regulatory Strategy: Experience in the development and approval of a product through the regulatory process
Experience in working with the development team in preparing FDA briefing documents, preparing for FDA meetings and participating in FDA meetings.
Experience in the review and strategy of developing NDA documentation.
Participating in and collaborating with both commercial and development in the labeling negotiations for a product approval.
Line Management: Functional responsibility for Medical Director(s), Director of Medical Alignment
- The expectation is that as the RCTA franchise develops additional medical staff will be required; therefore, the expectation is that the Medical Lead role will have functional line responsibilities for future medical staff.
Launch Experience: Experience developing and/or launching a new pharmaceutical product
- The RCTA franchise is expected to launch new indications, and products in the next 5 years; therefore, experience in the Medical Affairs roles and responsibilities will be important to lead this process
Global Interactions: Represent US Medical Affairs on Renal Cardio Global Medical Teams, incorporating US healthcare system perspectives and personal expertise into both the Global and US Medical Affairs strategy and operational plans.
- The US Medical Affairs team is an integral part of the overall global strategy. The Medical Lead sits on the GMT and is a critical leader in the strategic direction of the brand globally. The US Medical Lead will be working in a collaborative fashion with the Global Medical Affairs team to deliver both the strategy and overall operational plan for the US.
Drug development experience -- Know and understanding the nuances of pre-IND through Phase 3 drug development
Drug development experience is critical in the ability to create a robust LCM program
The Medical Lead will be responsible to provide advice on Business Development opportunities and be a critical partner in the due diligence assessment of potentially in-licensed products. The knowledge of drug development regarding preclinical, pharmacokinetic, dose-response, and Phase 3 development is essential to provide quality assessments
Many of our brands in development will be required to be presented at an FDA Advisory Committee. US Medical Affairs should be a critical partner with global drug development during this process.
Advanced scientific degree
Minimum 5 years in pharmaceutical/medical industry
Strong leadership skills
Proven teamwork and collaboration skills
Board Certification, experience/certification in Nephrology
Experience developing and/or launching a new pharmaceutical product
Broad cross-functional pharmaceutical and cross-functional general management experience
Strong scientific background; knowledge and experience in respiratory disease
Minimum 5 years experience in a strategy-setting role within Medical Affairs
Global experience within the pharmaceutical industry
Working knowledge of FDA requirements
Essential Skillsand Competencies:
Demonstrates strong leadership skills
Understands drug development of pharmaceutical products
Comprehensive understanding of pharmaceutical product planning, regulatory environment, marketing and promotion
Comprehensive understanding of the U.S. healthcare environment
Experience in a global organization
Previous line management experience
History of mentoring/development of others
Highly developed verbal and written communication skills
Shows initiative and innovation
Strong organization and time management skills
Strong analytical and problem-solving skills
Strong business acumen, including working knowledge of changing U.S. payer and provider landscape
Proven ability to interact productively 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 30-40% of time
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.