(Job Code WPM-7-2014)
We are seeking an experienced individual to manage the late pre-clinical and early stage clinical development of our lead internal program. The qualified individual will manage all internal and external efforts associated with the program and will lead our team’s activities providing technical support and regulatory documentation.
- Serve as program manager and provide leadership, coordination, and cross-functional communication to enable the team to meet its goals
- Develop initial drafts of key documents needed for regulatory filings and clinical study submissions
- Manage all project activities, control timelines, and manage resources
- Develop communications and presentations relating to project/program strategy, status, critical path activity timing, resources required, and related issues and/or risks, and communicate both internally and to partners as appropriate
- The ideal candidate will have a PhD, MD, or equivalent degree with a specialty in biology, chemistry, pharmacology, or other relevant discipline and at least 10 years of experience in an industry setting
- Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understanding of the preparation of regulatory submissions, including extensive experience with the CTD format supporting INDs, NDAs, and their foreign equivalents
- Demonstrated experience in study management/monitoring and data management, including trial site selection, CRO management, medical and scientific writing, and statistical analysis
- Strong understanding of Orphan Drug regulations
- Demonstrated project management expertise, including the leadership and development of cross functional teams
- Demonstrated ability to work independently with exceptional organizational skills and attention to detail in a highly focused and competitive environment
- Fluent in project planning software; PMP certification is a plus
- Excellent interpersonal, oral and written communication, and presentation skills
Interested candidates should submit a resume and cover letter to hr at rapharma dot com.
Ra Pharma™ is building a dynamic team of scientists to solve the most difficult problems in drug discovery today. We seek highly motivated individuals who enjoy working in a collaborative atmosphere and a goal-oriented environment.
Ra Pharma™ is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits and the opportunity for personal and professional growth in an outstanding and intellectually challenging work environment.