This is a temporary contractor opportunity at NovartisNovartis touches the lives of a tenth of the world's population. Every role here, regardless of contract type, makes an impact on human life! Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnitwww.magnitglobal.com Ready to work with/through Magnit at Novartis? Please read on... In planning for 2024, in the month(s) ahead, we anticipate hiring for this role:TheClinical Development Directoris the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), and/ or indication related clinical trial(s), under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase)Major Activities1) Provides clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols or substudies consistent with the Integrated Development Plans (IDP), clincal data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates, if applicable4) May be the Program Manager of other associates (e.g., CTH, CSE)5) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety6) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH7) As a clinical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards8) May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed9) Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support10) Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training11) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)Key Performance Indicators• Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables aligned with IDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders• Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases• Strong evidence of quality medical review of trial data; support TA through high quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables• Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators' Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders• Clearly demonstrates Novartis Values and BehaviorsEducation:Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferredExperience/Professional requirement:• = 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. = 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry• Advanced knowledge of assigned therapeutic area• Demonstrated ability to establish strong scientific partnership with key stakeholders• Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process• People management experience preferred, this may include management in a matrix environment.Global people management experience desirable• Excellent communication skills, written and oral• Strong interpersonal skills• Excellent negotiation and conflict resolution skillsLocation: East Hanover, NJ (Hybrid - 12 days per month onsite)Pay Range:$100.97 - $131.17 per hourContract: 12 monthsHealth, dental, vision, 401kWhy Novartis?766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine the impact you could make here at Novartis! Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. To do our best work we need different viewpoints,which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all. Accommodation:If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit ****** 1.862.778.5441. Commitment to Diversity and Inclusion / EEO
