Bank CV's - Incyte - Medical Director/Medical Monitor-Oncology

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.

The Director, Medical Monitor is responsible for providing leadership and establishing strategy and implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III).

Responsibilities:

• Leads oncology drug development at Incyte Corporation for successful implementation and conduct of clinical trials including early phase investigations and registration trials
• Provides medical and scientific leadership for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical scientists, biostatisticians, pharmacokineticists, pharmacovigilance and study delivery
• Interacts with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs).
• Facilitates the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSR, meeting abstracts and scientific journal publications
• Collaborates with external vendors such as CROs, external imaging and laboratory resources, as well as global pharmaceutical companies for successful implementation and conduct of early phase and registration global clinical studies
• Serves as a source for medical and scientific expertise in oncology for outlining design strategy and execution for anti-cancer drug development
• Liaises with discovery science to facilitate and further the development of
  investigational agents from a preclinical stage to clinical development
•  Represents Incyte Corporation at key national and international medical and scientific meetings including participation in advisory boards with key opinion leaders
• Detects and analyzes emergent issues during clinical drug development and develops and implements mitigating strategies
• Works in partnership with medical affairs for successful launch of future anti­neoplastic agents
• Implements the highest ethical and regulatory standards during the investigation and development of anticancer agents
• Provides guidance for successful implementation and accomplishment of investigator initiated trials related to product development and life cycle management of a compound

Requirements: 

• M.D. Degree 
• 7 - 10 years of industry experience in oncology drug development
• This position is responsible for providing leadership and establishing strategy and implementing clinical drug efforts for Incyte's oncology products (Phase I though Phase III).
• Strong interpersonal, verbal and written communication skills.
• Strong public speaking skills.
• Oral and written proficiency in English