Director, Safety Assessment

Novartis Institutes for BioMedical Research is Novartis' global research organization and is committed to discovering innovative medicines that cure disease and improve human health. By conducting more relevant and predictable drug discovery that can yield new and better medicines for patients, Novartis Institutes for BioMedical Research is redefining drug discovery in the post-genomic era. Over the past four years, Novartis Pharmaceuticals has had the greatest number of new molecular entities approved by the US FDA. With its broad focus on diseases for which there is a need for better medical therapies, and with over 3,000 talented, dedicated research scientists worldwide, Novartis Institutes for BioMedical Research is well-positioned to ensure Novartis maintains its strong pipeline and highly successful track record in new drug discovery. Novartis Institutes has sites in Cambridge, Massachusetts (headquarters); Basel, Switzerland; Horsham, UK; East Hanover, NJ; Vienna, Austria; Tsukuba, Japan and Emeryville, California. Novartis Institutes' Cambridge facilities encompass 950,000 square feet of laboratory and office space. Research in cardiovascular disease, oncology, infectious disease, diabetes, ophthalmology and muscle disease is headquartered in Cambridge. In addition, Cambridge is home to the following platform technologies: Global Discovery Chemistry, Functional Genomics, Developmental & Molecular Pathways, and Models of Disease Center. In order to attract and develop an exceptionally talented and committed staff, Novartis Institutes for BioMedical Research offers an innovative and comprehensive benefits package, including healthcare, insurance, savings, retirement, and work/life benefits. 1. Works directly with project/program teams in research ("discovery), exploratory development (ED, prior to proof-of-concept) and full development (International Project Team, IPT) to design and interpret the nonclinical safety aspects of drug development, including decision analysis, regulatory acceptability and issue resolution.2. Clearly identifies and communicates potential project hurdles, suggests solutions and establishes priorities and contingency plans in collaboration with Safety Profiling and Assessment (SP&A) line function management and project team participants.3. Negotiates with Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability of the sponsor's data.4. Assures SP&A line support to all assigned projects is optimal in terms of quality, timing and cost; negotiates these aspects with the line on behalf of the project team. 5. Responsible for compiling, gaining endorsement of and updating line function-specific development plans to support the candidate's Safety Profiling Plan (SPP) and Development Plan (DP). 6. Manages and provides constructive collaboration between technical experts in the SP&A line, and between the SP&A line and Research, ED and IPTs7. Manages the preparation and presentation of all internal and external documentation relating to nonclinical safety (e.g. Investigator's Brochure, IND, CTD, IMPD, Health Authority briefing books) documentation under minimal supervision or mentorship. 8. Manages communications and relationship-building with regulatory authorities worldwide in collaboration with Drug Regulatory Affairs (DRA) and the Head of Safety Assessment.9. Monitors timelines, objectives and budgets to align with development team goals. 10. Evaluates in-licensing opportunities and carries out Due Diligence activities.11. Leads or participate in Development or ED sub-teams and line function teams; represents the SP&A line on internal boards and with third-party organizations such as partners and scientific organizations. 12. Maintains scientific and regulatory expertise in the fields of drug development and safety assessment. Takes on leadership roles within SP&A in areas of expertise.13. Advises and mentors less-experienced and part-time SP&A Project Team Representatives (PTRs).14. Serves as core PTR (representing multiple lines) in project teams, if requested.15. May manage the comprehensive safety input for a disease area, working with other line representatives to set priorities, meet productivity goals, manage budgets and guide R&D investments. Member of a disease area decision board (DADB).QualificationsEducation (minimum/desirable): PhD in pharmacology, toxicology or a related biological science; MD with appropriate experience, DVM with appropriate training and experience. PharmD or equivalent with a strong biological background or equivalent work experience.Languages: Fluent English (oral and written). Experience/Professional requirement: 1. Level-dependent.o Base level: At least 2 years experience as a Novartis SP&A part-time PTR, or the equivalent experience in a similar external organization.o Senior level: At least 3 years experience in SP&A as a full-time PTR (preferably with a mix of research, exploratory development and full development teams), or the equivalent experience in a similar external organization. o Principal level: At least 5 years experience in SP&A as a Senior PTR and internal recognition as an opinion leader in one or more aspects of safety assessment, or the equivalent experience in a similar external organization.2. Advanced knowledge of the many scientific disciplines involved in drug safety assessment and the relevant laboratory tools and procedures related to safety assessment and risk management.3. Documented expertise in scientific and technical problem-solving in an international, multi-disciplinary, project-driven environment.4. Proficient with full range of techniques used in job and core area--especially with communication and negotiation with global health authorities. 5. Detailed knowledge of drug development processes and workwide regulatory guidelines and procedures.6. Ability to manage conflicting expectations in a matrix environment. 7. Proven negotiation skills.8. Excellent program and project management skills. 9. Team player behavioral attributes. 10. Self-motivated and able to operate independently.11. Ability to coach and advise colleagues in project-related matters (at senior and principal levels). Novartis Institutes for BioMedical Research is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V Job ID: 28770BR