BrightOwl Loader Loading

Associate Director, Clinical Development - Hematology/Oncology - Ireland  

Company managed [?] Still accepting applications

Posted on : 05 April 2017

Project Description


Description:
  • Our company  is seeking a clinical development associate director to join a team in hematology oncology drug development. 
  • You will be responsible for development of international clinical studies, the oversight and interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory and business development, and with external stake-holders including regulatory agencies and thought leaders.



Essential Functions
  • Provide clinical/scientific input during the development, execution and completion of clinical trials
  • Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results
  • Monitor clinical trials for safety
  • Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
  • Devise strategy for development and implementation of clinical studies for both investigational medicines and new indications for approved medicines
  • Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
  • Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjuction with project team members, regulatory affairs and senior management
  • Serve as medical representative with regulatory agencies
  • Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
  • Lead clinical advisory board meetings to obtain strategic input into clinical program development
  • Serve as medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, business development and investor contacts. 



Required Knowledge, Skills, and Abilities 
  • Pharmaceutical development experience, preferably in hematology/oncology, or completion of specialty certification in hematology/oncology
  • Demonstrated scientific and therapeutic expertise
  • Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
  • Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships
  • Excellent organizational and time management skills, ability to lead and manage multiple complex projects
  • Demonstration of company values in previous employment
  • Ability to work proactively and effectively, with creative problem solving skills
  • Travel up to 10%-20% of the time 


Required/Preferred Education and Licenses
  • Medical degree, MD or equivalent (DO, PharmD, PhD), with experience in hematology/oncology 


Description of Physical Demands
  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery. 


Description of Work Environment
  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.