Clinical Scientist Basel, Switzerland | Full-Time | Permanent
vor 12 Stunden
Who we are
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs. By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
About the role:
As a Clinical Scientist, you will provide support in the clinical development activities for the execution of clinical trials phase I-IV. The Clinical Scientist will work together with the clinical team toward efficient execution, high quality and timely deliverables of all associated aspects of the trial, in compliance with the company’s SOP, countries’ regulatory requirements, and Good Clinical Practice guidelines.
Core responsibilities:
- Author and/or review clinical study documents including clinical trial protocols and amendments, Informed Consent Forms, Statistical Analysis Plan (SAP), Case Report Forms, laboratory documentation, Investigator Brochures, etc.
- Ensure that the study documentation is developed following ICH-GCP, with respect to subject assessment of eligibility, enrolment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system (QMS).
- Provide scientific and clinical support to inhaled therapeutics programs overall ensuring the clinical perspective is captured in all key discussions and documents, e.g. Targeted Product Profiles, Clinical Development Plan/Integrated Development Plan, Clinical Evaluation Reports, User specification for device, Regulatory strategy, including submissions, filling, label extensions etc.
- Participate in clinical data and medical review.
- Participate in clinical operations activities requiring scientific input e.g. internal and external meetings, investigator meetings, discussions with CRO/vendors/third parties.
- Contribute to the clinical assessment team activities (assessment plans, presentations, publications, and literature searches).
- Provide input to clinical program documents i.e. clinical development plans.
- Interact and collaborate with other functions with the clinical study: CROs, regulatory, statistics, data management, quality and safety teams etc.
- Participate and present at KOL AdBoards.
- Scientific/Clinical support for regulatory submissions, meetings with FDA/Health Authorities and preparation of relevant clinical sections of regulatory documents i.e. briefing books and others.
- Lead the delivery of the clinical strategy for assigned investigational products.
Role Requirements:
Personal characteristics will be crucial, as the successful individual needs to have the self-sufficiency, energy, and drive to take this opportunity and run with it, with exceptional communication and leadership skills, as well as a level of comfort at working in a fast-paced setting. Specifically, the ideal candidate will possess the following:
- PharmD, PhD or MSc in Life sciences with experience in clinical research gained in pharma, biotech or CRO industry in a similar position.
- Experience in designing early and/or late clinical studies with good understanding of overall drug development.
- Hands-on experience in authoring clinical trial protocols, ICFs, IBs and other clinical documents.
- Hands-on experience in data review and protocol deviation processes.
- Hands-on experience in clinical scientist activities related to study startup, conduct and close out including CSR authoring and data publishing.
- Overall good understanding of the drug development process, related regulatory requirements, roles and responsibilities of core clinical team members.
- Experience in interacting with health authorities, providing clinical input to briefing and submission documents, responding to deficiency letters and queries.
- Experience in working with CROs.
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is 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.
Apply
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