Executive Director Rheumatology
N/A, MD, USA | Job Juncture
Industry:HR / Recruitment Services
Job Description:52 people have viewed this job
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 Iteractions: 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.
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
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
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