Associate Director, Clinical Development - Hematology/Oncology - Ireland
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- 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.
- 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.