This is a Director level position. As the MAPS lead, you will have the primary responsibility for further developing Amgen s Maternal and Pediatric Safety (MAPS) function in the department of Global Regulatory Affairs and Safety. In addition, you will work collaboratively with internal stakeholders to plan the overall strategy for MAPS.
You will work directly on high priority projects in the field of maternal and pediatric safety (MAPS) and provide senior expertise to support other colleagues who are working on one or more of the company's therapeutic areas (general medicine including nephrology and osteoporosis/bone loss, inflammation and cancer therapeutics/supportive care).
You will provide strategic support across the full spectrum of drug development (early pipeline through to marketed products). You will be responsible for working with MAPS function members to enable high quality support to functions globally.
You will also: - Interact with regulatory agencies upon request from the Global Safety Teams (GSTs), Global Development Teams (GDTs), and Global Regulatory Teams (GDTs). - Represent Amgen in professional organizations and specialty committees. - Propose and assist in implementing methods to increase subject enrollment and minimize attrition in pregnancy and pediatric registries and lactation studies. - Provide consultation to Preclinical, Clinical Development, Global Safety, and other Amgen functional areas and teams regarding pregnancy and lactation issues - Review and propose language for Study Concept Documents, Statistical Analysis Plans, and Proposals; Package Insert; Informed Consent Form; Investigator s Brochure; Data monitoring plan; Data collection forms; Risk Evaluation and Mitigation Strategies, Risk Management Plans, etc. - Review and provide input to the Maternal and Pediatric Safety Periodic Reports, including individual and aggregate case analyses. - Review industry partner reports. - Propose external presentations (oral and posters). - Publish (journal articles, chapters, abstracts, etc). - Participate in Safety agreements with business partners for studies. - Review and propose language in outsourcing contracts. - Give seminars within Amgen. - Train on internal processes (e.g., Standard Operating Procedures, Business Practices). - Train Local Safety Offices on data collection. - Train Contract Research Organizations.
MD or DO (or international equivalent) plus 2 years clinical experience
Preferred:
MD/PhD in Epidemiology, Developmental Biology, Toxicology (or related field) Residency completed in Ob/Gyn or pediatrics You will have a national reputation in your field and a track record of high quality research and publications, with experience in program development. Expertise and/or interest in pregnancy, lactation, and pediatrics is also preferred.
