Senior Global Clinical Trial Manager Phase I & II (temporary 12-months)

Job content

Description

Debiopharm is 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 (temporary 12-months)

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
Possibility to work from home with monthly visit in the office (Lausanne)
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.