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.

The Role

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.

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