Clinical Program Leader

pLocation: Basel /p pExperience will determine which level 6 (Senior CPL or CPL) after interview process. /p pCPL: Provides strategic medical guidance and leads the development of experimental oncology agents in the TCO portfolio, beginning with PE / DC (Portfolio Entry / Drug Candidate) of preclinical development and continuing through TDP (Transition Decision Point). /p h3About the Role /h3 pbMajor Accountabilities /b /p ul liProvides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DC /li liCreates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy. Delivers solutions within functions, across functions, and on global projects, developing independent approach to TCO strategy. /li liAlthough registration studies are not within the responsibility of TCO, the CPL must provide an early clinical development strategy that foresees and supports subsequent registration trials. Development of the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy Growth (SG), and Commercial teams /li liLead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP. May lead multiple global project teams /li liIntegrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets implications for clinical development, as articulated in the Investigator’s Brochure and First-in-Human protocol /li liCollaborates with clinical scientists to develop clinical protocols for TCO compounds and develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports) /li liApplies own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility. Knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them /li liLiaises with outside experts, investigators, and regulatory authorities in oncology, and represents own projects to those groups and authorities /li liWrites and reviews abstracts/manuscripts etc. for presentation/publications at internal/external meetings /li liParticipates in task forces to support continuous improvement and other management objectives. Operational responsibility for quality and compliance /li liMay provide informal mentorship to less experienced CPLs /li /ul pbQualifications: /b /p pbEducation: /b /p pMD or DO degree /p pBoard-certification in an oncology specialty and PhD-level science is preferred /p pbLanguages: /b /p pFluent English – Oral and written /p pbExperience/Professional requirement: /b /p ul liA minimum of 2 years of industry experience within pharmaceutical or biotechnology organizations is required, including experience contributing to and driving early clinical oncology programs. /li liExperience in the interpretation of preclinical oncology data, including molecular biology, pharmacology, pharmacokinetics, and toxicology, is also required. Prior experience in early-phase oncology at an academic medical center is highly desirable. /li liRecognized as an expert in your field by external medical experts and regulatory authorities. External candidates have a substantial record of publication and international recognition /li liExcellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology) /li liStrong knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials /li liProven ability to analyze and interpret efficacy and safety data relating to oncology /li liKnowledge of GCP and world-wide regulatory requirements for clinical trials and oncology /li liExcellent medical/scientific writing skills /li liSuccessful track record of strategic thinking: created major innovations with successful outcomes for patients /li liProven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment /li liExcellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies /li liExcellent written and oral English communication/presentation skills /li liStrong office IT skills /li /ul pbRewards /b /p pAt Novartis,we’recommitted to reimagining medicine together - and rewarding the people who make it happen. /p pThe rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits inkindto help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeingresourcesand global recognition programs. In addition, we provide flexible and hybrid working options, where possible, anda minimum of14 weekspaid parental leave. /p pExpected Annual Base Salary Range for role: /p pThe salary offered isdeterminedbased on gender-neutralobjectives, such as relevant skills,competenciesand experiencein accordance withthe Novartis pay setting policy and upon joining Novartis will be reviewed periodically. /p pIn addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. /p pPay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse,equitableand inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. /p pNote: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the applicationprocess. /p pbCommitment to Diversity and Inclusion / EEO paragraph: /b /p pNovartis is committed to building an outstanding, inclusive work environment and diverseteams’representativeof the patients and communities we serve. /p pbWhy Novartis: /bHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating,supportingand inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? /p pbWhy Novartis: /b Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? /p #J-18808-Ljbffr