OverviewUlcerative colitis and Crohn's disease, along with other gastrointestinal ailments, represent a diverse array of conditions impacting millions globally. These afflictions have significant unmet medical needs and often lead to a diminished quality of life. Novartis stands at the forefront of pharmaceutical innovation in immunology, leveraging advanced scientific research to develop transformative treatments that enhance patients' lives worldwide. We are seeking a Medical Director or Executive Director of Gastrointestinal (GI) Immunology in Translational Medicine Immunology. Join us in this endeavor!ResponsibilitiesDrive success of early global programs, develop and implement strategies to achieve Transition Decision Point (TDP).Drive success of late global programs by developing and implementing strategies, which lead to clinical pharmacology and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling.Support Translational Research in developing new indications, endpoints and biomarkers, using in vitro, in vivo, or in silico methods.Provide scientific expert assessments and support for in-licensing opportunities, including due diligences.Major AccountabilitiesEarly Clinical Projects (Phase I / II, “Discovery”)Develop, in collaboration with TM TA Head and work with teams to carry out, strategies for the Translational Medicine component of drug development projects from Research to TDP in single or multiple indications, including post-indication expansion projects.Lead global project teams through phase I/IIa to drive implementation of the development strategy.Convene relevant (internal and external) experts to consider the proposed approach to reach TDP; present plans for approval at relevant decision boards.Be responsible for clinical portions of the Integrated Development Plan (IDP, including the Clinical Development Plan and Clinical Profiling Plan).Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders.Late-stage Clinical Projects (post-TDP, “Profiling”)In collaboration with TM TA Head or Translational Medicine Profiling Head: Act as a key leader in developing the Ph2-3 and post-approval profiling strategy for drug programs, representing TMDP on Global Project Team (GPT) along with other TM line functions.Provide support for dose selection, study design and other clinical pharmacology matters throughout the development cycle.Oversee conduct and interpretation of studies prioritized to support the pivotal trials, such as special populations, drug-drug interactions, mechanism of action assessments, Pediatric Investigational Plan, etc.Drive analysis of studies and presents results to relevant decision boards.Communicate clinical team matters to GPTs and relevant BR and Development boards (and other Novartis Boards).Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders.Be responsible for writing TM portion of documents needed for regulatory submission through drug registration (including advisory committee and scientific advice group meetings).Translational Research (TR; indication seeking, endpoint and biomarker development)In collaboration with TM TA Head, BR Research scientists, other TM line functions develop strategies to identify initial or expansion indications and to obtain sufficient evidence to fund these ideas.Identify, develop, and implement strategy for preclinical support of clinical program-related scientific objectives, including assessment of medical need, proposed development pathways, review of preclinical data for clinical implications, and other relevant activities.Methodology studies to identify and validate novel endpoints for early decision making in Phase IIa studies.Be accountable for compound-related biomarker strategies; work closely with Biomarker Expert in implementation.Business Development and Licensing (BD&L)Participate on BD&L teams as the TM representative.Evaluate risks and benefits of potential in-licensing opportunities, identifying strengths and weaknesses of external programs in terms of TM’s scope of responsibility.Participate in teams carrying out out-licensing of BR programs as subject matter expert for disease indication, molecule, and clinical trial experience.LeadershipLead study-specific teams/clinical trial teams in partnership with other line functions.Lead BR-sub-team(s) on Global Project Teams for late-phase programs.Collaborate with other TM and non-TM functions to ensure operational excellence, timely delivery, cost management, and high scientific standards.Key Performance IndicatorsDelivery of proposed Development Candidate (B)DC and Integrated Development Plan Approval (IDPA) milestones, and results driving decision-making for/against transition into later phase development (TDP), according to defined timelines. Delivery of Clinical pharmacology and profiling strategy including execution of studies to support regulatory submissions and approvals. Delivery of TR plans to drive program strategy and trial efficiency. Leadership that builds high-performing teams and maintains operational excellence while upholding Novartis values and behaviors.ImpactDesign and implementation of early Integrated Development Plan (IDP) and studies to enable efficient decision-making and fast drug registration, high-quality labeling, and competitive compounds. This role impacts the entire Novartis pipeline from preclinical to full development and drives profiling data for regulatory submissions. Recognized expert in the field, influencing global project strategy across Novartis.Role RequirementsEducationDoctoral degree, MD required in most cases. PhD or relevant scientific experience with an academic track record preferred.Experience/Professional RequirementAt least 5 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience. Strong publication record, excellent written and oral communication skills. Ability to work independently and innovate. Recognized expert in the field with cross-functional respect.LanguagesFluent English (oral and written).About Translational MedicineTranslational Medicine is a global group of scientists and physicians working at the pre-clinical and early clinical stage of drug discovery. Our Physician-Scientist Discovery & Profiling group drives innovative science from Discovery to the market and focuses on early clinical drug development with cross-functional collaboration to bridge preclinical research and clinical development, tailoring to patient needs and personalized medicine.Diversity, Inclusion, and AccessibilityNovartis is committed to diversity and inclusion and to providing reasonable accommodations in the recruitment process or for the essential functions of a position. For accommodation requests, please email diversity.inclusion_ch@novartis.com and include the job requisition number.Join our Novartis Network to hear about opportunities and learn more about Novartis careers: https://talentnetwork.novartis.com/network
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