von: Teoxane SA | localité: GenèveN: TeoxaneSA
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Senior Clinical Program Manager
Teoxane Laboratories, established in Geneva, Switzerland, in 2003, are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.
In the frame of the growth of our business, we are looking for a:
Senior Clinical Program Manager US
(1) Responsible of implementation the US clinical programs from an operational perspective in full compliance with regulation and internal quality standards
- Manages clinical study team to ensure clinical programs are completed according to clinical development plan, on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines to meet organizational objectives
- Own and disseminate the vision, mission, values and strategic plan of the organization to team members and ensure adherence to these by team members.
- Responsible of CRO selection, budget and contract negotiation with the CRO for each assigned study/program.
- Ensure appropriate selection of investigational sites needed for assigned studies/program.
- Responsible for the development and quality of the essential documentation related to the assigned clinical program (s)
- Responsible for the budget and Key Performance Metrics of the clinical program(s)
- Responsible for the performance evaluation and development of team members.
(2) Serve as Point of contact for competent authorities (FDA), leading the IDE and PMA Submission
- According to the company clinical strategy, develop a US clinical plan adapted to new product/indication development and taking in full compliance with FDA requirement and internal quality standards.
- Align US clinical program to other related programs facilitating approval of our products in other regions outside of US.
- Take the lead of all interactions with FDA (Q-sub, IDE, supplements, annual reports and PMA).
- In close collaboration with PMO and regulatory team, manage IDE and PMA dossier development and its submission.
(3) Act As Subject Matter Expert for the US clinical development program, working closely with the Alliance lead and our local partner.
- Serve as primary point of contact with our US distributor medical team, participate to medical meetings & congresses and collaborate / influence their clinical strategy in US while ensuring that Teoxane US clinical strategy is implemented.
- Participates to Cross functional team to ensure delivery on time and within budget of assigned clinical program.
- Implement the clinical strategy linked to the clinical program(s) including but not limited to:
- Provide inputs during analytic development of the product.
- Analyze competitor clinical trials and strategy.
- Develop study design according to strategic and analytic development needs.
- Set-up of advisory boards with physicians to support clinical program(s).
- Analyze in collaboration with Medical Affair team the evidence needs and dissemination plan.
- Provide support to marketing campaigns.
- MSc degree in relevant scientific discipline e.g., Biochemistry, Microbiology, Pharmacy, Biological Sciences or related Pharmaceutical Science.
- Minimum 10 years' experience in clinical operations.
- Proven experience in US clinical trial management with interaction with the FDA.
- Team leadership and management experience.
- Outstanding communication and presentation skills.
- Strategic thinking and operational skills in the management of clinical programs.
- Ability to interact with cross functional teams both internally and externally (doctors, distributors, local authorities).
- Fluency in English (C1), good knowledge in French (B2).