Medical Director 2-Part Time

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Qualifications

What do you need to have?
  • MD or internationally recognized equivalent plus 5-8 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company.
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU is desired.
  • NDA/MAA Submission experience preferred
  • Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred
Skills
  • Superior communication, strategic, interpersonal and negotiating skills
  • Ability to proactively predict issues and solve problems
  • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
  • Diplomacy and positive influencing abilities across multinational business cultures
Knowledge
  • Knowledge in Pulmonology, Hematologoy or Immunology related specialties relevant to disease mechanisms and plasma derived/related therapies
  • Board certification/s in related specialty areas is desired
  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in plasma derived/related therapies
Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Responsibilities

What you will be doing?Clinical Development team participation and leadership
  • Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
  • Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
  • Drives all Clinical Medicine department activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to the medical directors, assoc. med directors, clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.
  • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
  • Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance.
External Interactions
  • Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the others engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
Due Diligence, Business Development and Alliance Projects
  • Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Sponsor's PDT BU's strategic goals while striving to maintain good working relationship between Sponsor's Plasma Derived Therapy Business Unit and partner. Provides guidance to others who are involved in some of these activities.
Leadership, Task Force Participation, Upper Management Accountability
  • Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned compounds. Represents clinical science on high impact/priority task forces across the organization or external to the company. Leads PDT R&D internal teams and global cross-functional teams.


United States-Remote