VP, Global Clinical Pharmacology in Genève

pTelix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. bAt our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. /b /ppYou will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. /ph3See Yourself at Telix /h3pThe VP Global Clinical Pharmacology (VPGCP) is the senior leader and subject matter expert (SME) for Clinical Pharmacology and Pharmacometrics within the Telix Group. The VPGCP leads and is accountable for all Clinical Pharmacology activities required during the advancement of Telix's Therapeutic and Precision Medicine radiopharmaceutical drug candidtes from First in Human (FIH) studies through to Phase 3 registration-enabling studies, including those activities specifically required by global Regulatory Authorities (e.g. U.S. FDA, EMA, U.K. MHRA, TGA, NMPA, PMDA etc.) and Payers. /ph3The VPGCP Is a Strategic Leadership Position That Will /h3ulliCollaborate with the SVP Clinical Science – Therapeutics, SVP Clinical Science – Precision Medicine, SVP Innovative Medicines, Global Development Leads (GDLs), Global Clinical Leads (GCLs) and cross-functional teams to define, lead and execute the Clinical Pharmacology strategy during the development of Telix's Therapeutics and Precision Medicine drug candidates /liliDefine, lead and execute the Clinical pharmacology strategy during the development process from IND/CTA, through first registration, indication expansion, registration in new geographies and lifecycle management /li /ulpBuild, lead and mentor a team of Clinical Pharmacologists and Pharmacometricians with a broad experience base required to support all Telix Group drug development activities. /ph3Key Accountabilities /h3ulliCollaborate with the SVP Clinical Science – Therapeutics, SVP Clinical Science – Precision Medicine, SVP Innovative Medicines, SVP Reseach Development, GDLs, GCLs and cross-functional teams to define, lead and execute the Clinical Pharmacology strategy during the development of Telix's Therapeutics and Precision Medicine drug candidates, including early Translational Medicine programs /liliEnsure that the Clinical Pharmacology strategy is aligned to:ulliTelix's Purpose, Mission and Values /liliAnnual Corporate Objectives /liliTherapeutics and Precision Medicine Business Unit Priorities /liliRegulatory and Market Access requirements /li /ul /liliDesign, implement and govern Clinical Pharmacology strategy across Telix's development stage portfolio, with a focus on clinical trial design, via:ulliDefining portfolio-level quantitative decisions for dosing regimen justification and optimization, as well as asset differentiation (e.g. mass dose, radiation absorbed dose, dose regimen optimization, dose intensification, dose adaptation) /liliDefining Model-Informed Drug Development (MIDD) standards and modeling governance /liliEngagement with KOLs through Scientific Advisory Boards (SABs) and Study Steering Committees /liliInteractions with global Regulatory Authorities and Payers /liliEnsuring adherence to study protocols, ethical standards, and relevant regulatory requirements, guidelines and standards /li /ul /liliSupport Executive decision making using quantitative data to shape dosing regimen strategy during the development of Therapeutics and Precision Medicine assets /liliServe as a thought leader SME, who is able to present relevant Clinical Pharmacology and Translational Medicine data "on the podium", "beside the poster" and "in front of KOLs" (e.g. at Scientific Congresses and Symposia) /liliEvaluate and integrate emerging modeling approaches and clinical data to inform decision-making and identify opportunities for pipeline expansion and optimization. /li /ulh3Clinical Pharmacology SME /h3ulliDesign, oversee, analyse and interpret Pharmacokinetics (PK), Pharmacodynamics (PD), and Dosimetry studies /liliConduct and oversee population PK/PD and Exposure-Response Modelling through Model-Informed Drug Development (MIDD) approaches to support dose regimen selection, dose optimization and individualized/fractionated dosing strategy /liliConduct and oversee Physiologically-Based Pharmacokinetics (PBPK) and Dosimetry modelling in collaboration with Radiochemistry and Medical Physics team /liliGuide theranostic pairing strategy, linking companion diagnostic imaging data to therapeutic dosing and patient selection algorithm in collaboration with Global Clinical Science Leads. /li /ulh3Regulatory And Cross-Functional /h3ulliAuthor and review Clinical Pharmacology and Dosimetry sections of submissions to global Regulatory Authorities (IND/CTA, IB, briefing books, NDA/BLA/MAA) through first registration, indication expansion, registration in new geographies and lifecycle management /liliLead Clinical Pharmacology representation in interactions with Regulatory Authorities, including for specialized radiopharmaceutical review divisions /liliContribution to target product profiles, integrated development plans and regulatory strategy /liliSupport CMC / Radiochemistry in radiolabelling, specific activity and formulation considerations that impact PK and dosimetry /liliCollaborate with Nonclinical and Translational Medicine for first-in-human dose selection, and with Biostatistics for MIDD /li /ulh3Lead The Global Clinical Pharmacology (incl. Pharmacometrics) Team /h3ulliLead the Global Clinical Pharmacology team across development programs in Prostate, Renal, CNS and Musculoskeletal cancers, and Rare Diseases, to ensure that each of these Disease Areas is able to maximize its value of the Company’s clinical development programs, and ensure the safe, ethical and compliant development of Telix's products /liliTogether with the Global Clinical Science team, lead the dosing regimen optimization and actively contribute to the design of clinical trials, including but not limited to study protocol, endpoints and statistical plan, to generate decision-grade data /liliAdvocate for and instill within the Global Clinical Pharmacology team the importance of Telix’s values: Everyone counts; we strive to be extraordinary; we act with determination and integrity /liliDemonstrate leadership for Telix’s Quality, Governance, and Compliance systems through active promotion of standards and procedures and ensure that team members are suitably trained and developed to perform roles effectively and safely /liliTake an active interest in team members and their well-being, and endeavor to attract, develop and retain the best talent, to deliver Telix’s current and future business objectives. /li /ulh3Education And Experience /h3ulliPharmD is required /liliAdditional post-graduate qualification is preferred, g. PhD in Clinical Pharmacology or closely related relevant field /liliMinimum of 15 years’ industry experience in RD and Clinical Development, within a pharmaceutical or biotechnology environment, including senior leadership roles is required /liliExperience within Oncology and/or Radiopharmaceutical drug development is required /liliExperience in early, mid, and late-stage development, in generation, selection and execution of strategy for clinical data analyses and interpretation /liliDemonstrated knowledge and prior success with global regulatory requirements governing dosing regimen optimization within clinical development and drug approval and market access processes /liliExcellent communication, interpersonal, and leadership skills, with the ability to influence others and collaborate effectively across diverse and opinionated stakeholders /liliProven track record of strategic thinking, decision-making, and problem-solving in complex and dynamic environments /liliCommitment to integrity, ethics, and patient-centricity in all aspects of /li /ulh3Key Capabilities /h3ulliCommitment to excellence: Take pride in your work and consistently strive for excellence in everything you do /liliResults-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results /liliCreativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges /liliStrong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language /liliCollaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals /liliResilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges /liliInclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected /liliAdaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges /liliEthical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders /liliContinuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills /li /ulpAt Telix, we believe beveryone counts /b, bwe strive to be extraordinary /b, and bwe pursue our goals with determination and integrity /b. You will be part of an engaged and supportive group of colleagues who all have a sharedb purpose: to help people with cancer and rare diseases live longer, better quality lives. /bBeing a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. /ppTelix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. /ppVIEW OUR RECRUITMENT PRIVACY POLICY HERE /p #J-18808-Ljbffr