Medical Lead

Job Description

Dozens of opportunities to work collaboratively across different functions. In Medical Affairs we are encouraged to collaborate grow, and work on new ways to increase our impact in the community. Position PurposeFocus on optimizing patient access and outcomes by providing up-to-date compound and disease area medical expertise, acting as a key expert in the relevant therapeutic area assigned, and leading across functions to address external and internal stakeholder needs. To shape and implement the Local and Global Therapeutic Area strategy through innovative integrated evidence generation, engagement on scientific results with internal and external stakeholders, and co-creation with healthcare systems and the scientific community. To co- design clinical development launch and life cycle management of the drug in close collaboration with Country, Regional, and Global team members. To ensure that the best interest of patients and those who care for them are identified and met.Your responsibility includes, but not limited to - Proactively contributes to prepare and drive the execution of the local Medical Affairs strategic plans aligned and in collaboration with other functions. This plan should be built based on local stakeholder needs and in line with the Franchise and medical strategies as outlined in the Integrated Product Strategy (IPS) Plans. Lead early identification of strategic drivers, elaboration of patient journey, positioning, target population, the wider stakeholder population mapping and segmentation. Identifies opportunities for joint value creation through engagement with the key scientific leaders and other partners in the healthcare systems including Patients and Patient Associations to co-design strategies and studies, advocating in the assigned therapeutic area. Utilizes Omnichannel where possible Gathers and internally shares relevant captured insights (advisory boards, events etc), to shape the disease area strategy. Accountable to Co-developing integrated evidence plans and ensuring local execution of these plans early in prelaunch stage and throughout the lifecycle in partnership with Global Drug Development (GDD), functional partners, healthcare systems, patients and other external stakeholders. Identifies Real World Evidence (RWE) needs and utilizes implementation science and other innovative methodologies, to close the gap ensuring patient and clinical adoption and better outcomes. Responsible for local and global evidence generation submissions Leads the Post Trial Access (PTA) for local phase 4 studies as clinical study manager (CSM) and Managed Access Programs (MAP) at local level, evaluates Investigator-Initiated research studies and Trials (IITs) and Research Collaborations (RC) for scientific rigor and alignment. Provides key medical expertise on the company s pipeline programs, disease areas and approved brands. Performs comprehensive evaluation of related products passing DDP/FDP to enable effective cross-functional New Product Planning for the Country Pharma Organization (CPO). Provides informed CPO input to Global strategies, protocols, etc if assigned early product portfolio. Raises awareness of Novartis brands, programs, and disease areas through publication of manuscripts, scientific presentations, projects and educational trainings as well as acts as company ambassador in external scientific programs and congresses. Provides medical expertise and leadership to functional partners through the life of the product(s) by Working as a strategic partner in collaboration with, Clinical Research Medical Advisors (CRMA), Marketing, Value Access and Commercial Development (VACD) Patient Advocacy, Public Affairs and GDD teams, where necessary, to ensure effective patient outcomes and access. Co-creating, and along with project owner, ensuring that all Medical and Promotional activities and materials are compliant to Novartis and Pharmaceutical Industry procedures, and to National laws and regulations. Supporting and partnering on training activities to Commercial, Clinical Research Associates (CRAs), Clinical Study Managers (CSMs), etc Supporting Drug Regulatory Affairs (DRA) team on regulatory documents, filing and health authorities interactions. Key role in governance of external funding, advisory boards, HCP/ HCS engagements and patient support programs. In collaboration with ERC responsible for the alignment of local Medical Affairs compliance initiatives, policy interpretations, risk mitigation, trainings, and corrective actions related to medical. Represents those who practice medicine and brings an understanding of how patients are cared for into the work of their therapeutic area, ensuring that activities are in the best interest of patients and those who manage them. Ensures Target Patient Population Outcomes (TPOs) are updated and relevant, and that they are being tracked, resourced and impacted at CPO level with appropriate regional and global support. Strong relationships (with country key healthcare system scientific leaders, patients and patient advocacy groups) and captured insights, lead to identified opportunities for joint value creation and co-designed strategies and studies Early Implementation research and scientific plans leads to all possible barriers to access clarified, seamless launch, with optimized access and adherence for patients EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements Ideal BackgroundEducation: MBBS+MD/MBBS in Health sciences. Languages: English: fluent spoken & written Expereince: At least 2 years of relevant expereince.Significant clinical and research background GCP. Strong medical and scientific bases and agility to transverse the diseases arena. Good planning and organizational skills. Strong business acumen, curious & growth mindset . Strong medical and scientific writing skills. Preferred experience in innovative study designs e.g. RCT/RWE mixed designs. Preferred experience in implementation science. Preferred proven track record of co-creation and co-execution of protocols with stakeholders in healthcare systems Why consider Novartis 769 million lives were touched by Novartis medicines in 2020, 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 our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do at Novartis! Commitment to Diversity & Inclusion:Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
strong business acumendrug regulatory affairsglobal drug developmentclinical research associatesenvironmental impact assessmentlife cyclepublic affairs