Medical Director/Exec. Director, Gastrointestinal (GI) Immunology (Translational Medicine)(m/w/x)

# Medical Director/Exec. Director, Gastrointestinal (GI) Immunology (Translational Medicine) **Basel (City)** | **Full time** **Band** Level 7 **Job Description Summary** Ulcerative 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! You will provide medical and scientific leadership and expertise in a role that significantly impacts the drug development pipeline. 1. Drive success of early global programs, develop and implement strategies to achieve Transition Decision Point (TDP) 2. 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. 3. Support Translational Research in developing new indications, endpoints and biomarkers, using in vitro, in vivo, or in silico methods. 4. Provide scientific expert assessments and support for in-licensing opportunities, including due diligences. **Job Description** **Major Accountabilities** **Early 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 by the 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 (BMD, CS&I, PCS, PKS), develop strategies to identify initial or expansion (PIE) indications, and to obtain sufficient evidence to fund these ideas. * In collaboration with research scientists, identify, develop, and implement strategy for preclinical support of clinical program-related scientific objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities. * This may include methodology studies to identify and validate novel endpoints for early decision making in Phase IIa studies. * Be accountable for compound-related biomarker strategies; works closely with Biomarker Expert in implementation. **Business Development and Licensing (BD&L; in-licensing and outlicensing compounds):** Participate on BD&L teams as the TM representative. * In collaboration with BD&L team, evaluate the risks and benefits of potential in-licensing opportunities, identifying the 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 the disease indication, molecule, and clinical trial experience. **Leadership:** * Lead 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 closely with other TM (especially CS&I) and non-TM (especially Project Management) line functions to ensure operational excellence, continued urgency, and close attention to timelines, costs, and subject burden in balance with high scientific standards and innovation. **Key Performance Indicators** Delivery 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 according to timelines to support regulatory submissions and approvals. Delivery of TR plans, whether in vitro, in vivo, or in silico, to drive program strategy and clinical trial efficiency. Team leadership skills that create high performing teams and drive efficient conduct of innovative, interpretable clinical results and a focus on operational excellence at all levels. Strong adherence to and modeling of Novartis values and behaviors. **Impact of this role?** Design and implementation of early Integrated Development Plan (IDP) and design and implementation of studies according to the IDP, enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds. This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the TDP mechanism, and driving the program after TDP by delivering key Profiling data to support regulatory submissions. Recognized Expert in field, drives project team clinical strategy. Works globally across Novartis. **Role Requirements :** **Education** Doctoral degree, MD required in most cases. PhD or relevant scientific experience with academic track record preferred Demonstrated excellence and clinical expertise in relevant medical subspecialty. **Experience/Professional Requirement:** At least 5 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience. Recognized medical expertise, as evidenced by publication of significant contributions to a field over time. Excellent written and oral communication/presentation skills. Independence: Able to work independently as outlined above, commensurate with level of role. Innovation: Seeks out new clinical discovery opportunities and approaches to reach TDP. Demonstrated passion for science. Recognized expert in field, driving success for individual studies and projects; respected by colleagues across R&D, Development, and externally. **Languages:** Fluent English (oral and written). **Skills Desired** Active Directory, Artificial Intelligence (AI), Classification Systems, Computer Data Storage, Critical Thinking, Higher Education, Initiative, Merchandising, Selling Skills