We are working with a pharmaceutical company located in Basel, Switzerland which is building upon proven safe and effective therapies and repurposing them using innovative delivering technologies.
With a strong focus on effective treatments for neurology and pain management.
Flexible working: office-based and home-based.
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.
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:
Lead the development of early and late clinical studies including:
Generation of concept sheets, synopsis, protocols, and related clinical documentation e.g., IB, ICFs, DSURs etc.
Presenting clinical plans and trials to internal scientific boards
In collaboration with project management selecting and contracting appropriate CROs, Labs and other vendors
Providing required clinical input in setup activities e.g., medical feasibility, countries and clinical site selection, support responding to HA/IRB deficiency letters, participating, and providing training at Investigator Meetings
Might provide input to SAP, RAP, eCRFs, DMP, DQP, PROs strategy etc.
Building and maintaining positive relationships with Key Opinion Leaders and Principal Investigators
Once running, lead the oversight of clinical studies in collaboration with the CRO.
Assuring scientific integrity and quality of clinical studies, might be involved in responding to PI queries and period data review etc.
Might be involved in relevant internal and external audit activities
Participating in safety data review or Data Monitoring Committees, if applicable.
Providing input to design requested by FDA (or other regulators) clinical trials to support the approval of the product
Providing input to device usability studies, where applicable
Analyze, interprets, and presents clinical study results to management and other stakeholders
Leads/oversights preparation of CSRs and relevant study publications
Might interact with global HA outside US
Participating and preparing content for Advisory Boards
Might be involved in defining innovative endpoints, digital strategies for assigned product etc.
Support GMA and other teams in developing scientific/Clinical launch strategy
Contributes to medical/scientific onboarding of relevant company’s stakeholders and employees
Might be involved in SOP and WKI authoring or revisions.
Experience and education
PharmD, PhD or MSc in Life science with substantial experience (3-5 years) in clinical research gained in pharma or CRO industry in a similar position
Overall good understanding of drug development process, related regulatory requirements, roles, and responsibilities of core clinical team members
Experience in designing phase 2 and phase 3 clinical studies and good understanding of early drug development
Experience in interacting with health authorities, responding to deficiency letters and queries
Experience in authoring clinical documentation i.e., protocols, amendments, ICFs, IB, DSURs etc.
Experience in working with CROs
***This position has now been filled, please contact firstname.lastname@example.org be informed of future similar positions***