| Job Description | The Symbicort Medical Lead is a member of the Respiratory Franchise Leadership Team and leads the Symbicort 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 FDA and has experience in clinical trials. An ideal candidate should have significant experience in respiratory disease management and would thrive on proactively engaging internal and external leaders. S/he is accountable for the development and execution of the US Symbicort Medical Plans, and leadership of the Symbicort Core Medical teams. The ideal Medical Lead would have a network of Allergist and Pulmonologist KOL 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.
Major Responsibilities:
Co-lead the Symbicort Brand team with the Commercial Brand Leader
Lead Symbicort 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 Symbicort Global Product Teams, incorporating US healthcare system perspectives and personal expertise
Internal Contacts/Customers:
Medical Affairs TA VP
Commercial Brand Leader
Director Medical Alignment/Field Leader
Brand Medical Directors
Brand Marketing Directors/Managers
Medical Information Managers
Medical Science Liaisons
Strategic Project Managers
Compliance
Corporate Affairs
Sales leaders
Regulatory Affairs Directors
Global Product Team
Patient Safety
External Contacts/Customers:
Key Opinion Leaders
Clinical Decision Makers
Advisors
Investigators
Speakers
Consultants
National Medical Societies
The rationale for the split banding of the role is that the Band G candidate should have experience in the below listed critical areas. The role will be critical in the approval of additional indications for Symbicort (COPD exacerbations and Pediatric) and also in the Pearl product approval process. Therefore, the below areas will be either critical to have or be able to be developed
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)
The expectation is that as the respiratory 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 respiratory franchise is expected to launch numerous new products, indications, and devices 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 Symbicort Global Product 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 Symbicort Medical Lead sits on the GPT 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.
Minimum Requirements:
Advanced scientific degree
Minimum 5 years in pharmaceutical/medical industry
Strong leadership skills
Proven teamwork and collaboration skills
Preferred Requirements:
Board Certification, experience/certification in respiratory disease
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
Minimum Skills and 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
Strategic thinking
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 |
| | Company | | AstraZeneca | Job Code | | State or Province | | Delaware | | |
|
