Biotech is a new business, bringing together two unique organizations: experts in inhalation technology and experts in oral and intra-oral delivery systems. We are driven by the exciting and unique goal of Revitalizing, Repurposing and Reimagining existing therapies to address some of today's unmet patient and consumer needs and to better serve people in taking care of their health.
What We Will Deliver
We aim to build upon products that exist today and make them better for consumers and patients tomorrow. By taking a holistic and human-centric approach to care, we will innovate the design and delivery of medicines and Consumer Health products that support overall health and wellness management. We will focus on the development of a proprietary pipeline of Prescription, OverThe-Counter (OTC) and Consumer products, with a specific focus on areas where we believe we can deliver best-in-class, and highly differentiated products that address existing unmet medical needs.
Wellness: Bring to market scientifically substantiated, botanical and cannabinoid products that help people take well-being into their own hands in the areas of Sleep, Energy, and Mental Health.
Healthcare: Develop and launch fast acting, effective and safe treatments in the field of cardiovascular diseases, neurology, and pain management-including medical cannabis-all of which can be delivered via innovative technologies.
About the role:
As a Senior Clinical Pharmacologist you will provide strategic input for early phase clinical studies within a cross functional team.
Core responsibilities:
*Supervise the design of early phase translational pharmacology studies for therapeutics across multiple disease areas to advise next phases of drug development. Critically evaluate relevant pharmacokinetics/pharmacodynamics data across in vitro, in vivo, and drug metabolism studies
for clinical study design to be part of the clinical development program. Identify relationship between drug exposure and efficacy outcomes and select the efficient dose & dosing intervals from review and interpretation of PK/PD data.
*Lead the selection, design, development/review of core clinical study documents and interpretation of data from early phase. Be responsible for the scientific aspects of studies and be the point of contact for CROs and investigators in day-to-day needs. Review and provide input to internal and external documents with scientific content, participate in data review process according to the Data Review Plan and review results.
*Actively support the clinical team activities when necessary, requiring scientific input, as well as ensuring interactions with regulatory, quality, legal departments, contribute to the resolution of issues and crises, keep effective communication among peers, ensure that issues, or relevant information, are raised and that feedback is sought, where needed, and a solution to open actions is achieved.
*Ensure that the clinical study documentation is developed following standard clinical research practices (ICH-GCP) as well as the quality management system applicable, participate in the writing, review, and update of SOPs and WKIs related to clinical assessment activities.
*Conduct data analyses including non-compartmental analyses, modelling and simulations, literature data analyses. Investigate, identify, develop, and optimize new methodologies and techniques in PK/PD field. Lead the writing of regulatory documents for clinical pharmacology sections. Contribute to provide scientific information for the registration / publication of results on ClinicalTrials.gov and in peer-reviewed journals.
Role Requirements:
*Scientific degree (PharmD or PhD).
*Substantial experience in a Translation medicine, PK, population PK (PBPK), PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters, clinical pharmacology and Modeling & Simulation (M&S), in GCP studies phase I&II, within the pharmaceutical, food, life sciences industry.
*Familiarity with quantitative approaches in drug development, good understanding of relevant modeling software (e.g. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus). Understanding of basic statistical methodologies, proficiency in performing literature review, familiarity with document storage and systems, expertise in working according to a quality management system and GCP.
*Proficient with Excel, PowerPoint, and Word.
*Fluent in English, both written and spoken.
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of consumers and patients. We are a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes.
As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings. We embrace hybrid and flexible working and are centered on delivering a 'purpose-driven' experience for all our employees.
Be part of an inclusive, diverse culture, where everyone's contribution is respected; collaborate with some of the world's best people and feel like you belong.
