CLINICAL SCIENTIST, ASSISTANT DIRECTOR CLINICAL DEVELOPMENT
SUMMARY:
The successful candidate will provide technical support to one or more Clinical
Project Teams to ensure the successful design and implementation of Clinical
Development Plans. Major areas of responsibility include contributions to
regulatory submissions and clinical data analysis.
RESPONSIBILITIES:
• Provide technical writing support for:
1. clinical study protocols and amendments
2. clinical study reports
3. clinical study manuscripts
4. regulatory documents, including investigator brochures
5. abstracts and posters for medical congresses
• Perform monitoring, and review study data including labs, safety and
efficacy data and patient eligibility
• Reviews of clinical trial-related documents including CRF, PD, MM Plan,
ODRP, and Adjudication plans/charter/committee reviews
• Interact with external medical/scientific advisors, thought leaders and
clinical investigators in the therapeutic areas as well as with internal
management and drug development staff to prepare/revise/maintain and
efficiently execute the drug development plan
• Contribute to the planning and design of clinical studies
• Represent Clinical Development in operational meetings and data
management meetings which includes being readily available to advise on
trial related questions or problems during the conduct of the trial
• Establish good working relationships with investigators
• Provide guidance and/or training for external personnel/parties involved
in Ionis clinical studies
• Develop external advocates for the company’s technology, products, and
direction
• Maintain clinical and technical expertise in the therapeutic area: review
scientific journals, attend scientific and key technical meetings and
partner with company medical, research and business teams
• Proactively provide feedback on emerging clinical/competitive trends
• Other duties as assigned
QUALIFICATIONS:
• Excellent attention to details
• Excellent written and verbal communication skills
• Knowledge of the drug development process
• Working knowledge of data organization and analysis
• Strong public presentation skills
• Comprehensive and detailed knowledge of clinical trial implementation
and sponsor/site interactions for clinical trials is preferred
• An ability to be productive and successful in an intense work
environment
EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS:
• Advanced degree (Ph.D., Pharm.D., M.D., Master’s Degree in Science/
Medical-related fields, MSN and PA) with 2-4+ years of Clinical Research,
Pharmaceutical or CRO experience