***Role can be based in Delaware, Maryland, UK, or Swededn
We turn ideas into life changing medicines. As the Immunology Medical Head, US Medical, youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives.
The Immunology Medical Head will be a member of the Immunology Leadership Team and will lead the US Core Medical Team for the specific assigned brand. The position can be either a Senior Director or Executive Director based upon the individual's experience. The Medical Head is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience with clinical trials. An ideal candidate should have significant experience in immunology and would thrive on proactively engaging internal and external leaders. S/he is accountable for the development and execution of the US Medical Plans. The ideal Medical Head would have a personal network of external experts in immunology as well as professional society relationships. As a member of the Global Medical Team, the Medical Head represents the US on life cycle management, labeling, and other externally sponsored research.
- Co-lead the US Brand team with the Commercial Brand Leader
- 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.
- Lead the delivery of U.S.-based evidence generation, 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 Affairs (as appropriate)
- Create an atmosphere of clear accountabilities.
- Ensure compliance with all company corporate policies
- Develop and maintain relationships with key external and internal stakeholders.
- As part of Medical Plan, ensure comprehensive engagement plan with customers and key stakeholders, e.g., Managed Care Organizations, External Scientific Experts, Key Institutions and Hospital Systems, Professional Societies
- Lead development of the US Advisory Board strategy
- Represent US Medical on the 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 Affairs
- The expectation is that as the immunity franchise develops additional medical staff will be required; therefore, the expectation is that the Medical Head role will have functional line responsibilities for future medical staff.
Launch Experience: Experience developing and/or launching a new pharmaceutical product or new indication of an existing product
- The immunity franchise is expected to launch new products and indications in the next 5 years; therefore, launch experience in the Medical roles and responsibilities will be important to lead this process
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.
- The US Medical 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 team to deliver both the strategy and overall operational plan for the US.
Drug development experience -- Know and understand 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 would be a critical partner with global drug development during this process.
- Medical Degree
- Minimum 5 years in pharmaceutical/medical industry
- Strong leadership skills
- Proven teamwork and collaboration skills
- 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% of time
- Board Certification, experience/certification in rheumatologic 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 rheumatologic/autoimmune disease
- Two years experience in a strategy-setting role within Medical in a pharmaceutical company
- Global experience within the pharmaceutical industry
- Working knowledge of FDA requirements
How To Apply:
You will be directed to another website for application instructions.