Associate Director, Clinical Development
|Job Title:||Associate Director, Clinical Development|
|Location:||San Francisco, California|
|Contact Name:||Pavlina Bullaj|
|Job Published:||July 31, 2017 18:42|
Associate Director, Clinical Development/ Director, Clinical Development
SciPro Global are currently looking for an Associate Director/ Director Clinical Development based in San Francisco or willing to relocate with a background in Hematology/ Oncology.
The Associate Director/ Director Clinical Development will support the Clinical Affairs, Regulatory Affairs, and the Research and Development will be responsible for the 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.
Role & Responsibilities
- 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 conjunction 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 and business development and investor contacts.
- 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 Client 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
If this is something you would be interested in, please apply to the role directly or send me an email to email@example.com
I look forward to receiving your application!
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