Head of Medical Affairs Renal

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Wilmington, DE
$1 - $1
Job Type
Direct Hire
Nov 15, 2018
Job ID
Renal Cardio Medical Head (Executive Director)
The Renal Cardio Medical Head 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.
Major Responsibilities:
  • 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 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.
Essential Requirements:
  • 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 renal 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 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