Senior Global Clinical Trial Manager Phase I & II

Job content

Debiopharmis an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique "development only" business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Here:https://apply.workable.com/debiopharm-group-sa/

To support our Clinical Operations Department based in Lausanne, Switzerland, we are looking for:

Senior Global Clinical Trial Manager Phase I & II

As Senior Global Clinical Trial Manager Phase I & II, you will contribute to delivering new medicine to the market through planning, leading and delivering international Phase I & II clinical trial. You will ensure that the assigned to you studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice. You will report to the Manager Clinical Operations.

Your responsibilities will be but not limited to:

• Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
• Manage operational and technical aspects of projects including budgeting, timelines and risk management
• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
• Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
• Monitor vendor and CROs performance and ensure continuous oversight
• Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
• Represent clinical operations on multi-function project teams internally and externally, if needed; report on study progress
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
• Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
• Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
• Design, review and approve of all trial related documentation, and establish trial processes

Requirements:

• Bachelor or Master degree or equivalent in Life Sciences
• Proven track record of 5-7 years of experience as Global Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase I & II studies from set-up to close-out
• As Global Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology (a must)
• Experience in leading global clinical studies in Phase III is an asset
• Experience in pharmacokinetic studies (e.g. DDI, ADME) is an asset
• Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
• Customer oriented and strong team-spirit with the ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization
• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
• Experience in external audits, an asset
• Strong negotiation skills, scientific knowledge and involvement
• Former experience in contributing to protocols and clinical development plans
• Fluent in English - French is an asset
• Travel: up to maximum 20%

Benefits:

• An international and highly dynamic environment
• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.