Head of Clinical Operations - Kaiseraugst, Schweiz - DSM

DSM

Geprüftes Unternehmen

Kaiseraugst, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Bring your passion. Build the future.

What you'll do

In this role, you will ensure positive impact on people's health and thus on DSM's overall business results through excellence in clinical research.

This impact is reflected in the contribution to the clinical development program and actual implementation of clinical operations in businesses, resulting in value-added products and solutions for our customers - with the ultimate goal to improve human health.

You will be accountable for delivering the clinical pipeline through leadership in clinical operations.

Furthermore, it is responsible for ensuring clinical trials are in compliance with the company's procedures, external regulations, and any other applicable regulatory and ethical requirements.

Your key responsibilities

Impactfully contributes directly or indirectly to the development of HNC's clinical strategy and ensures that associated strategic human study research requirements are implemented
Provides leadership in the development of the clinical trial management. Leads, coaches and develops the Clinical Operations team in supporting the conduct of clinical trials, by e.g. development of / access to resources, tools, SOPs, databases etc., incl. novel methods and technologies. Participates in development and maintenance of clinical SOPs, tools, and document templates.
Ensures that appropriate training and processes are in place and that the Clinical Operations team conducts its activities in accordance with health authority requirements and Good Clinical Practice (GCP)
Responsible for hiring and retaining a diverse Clinical Operations team of highly skilled professionals
Mentors and supervises Clinical Operations staff and develops plans to grow clinical research capabilities as needed according to the growth of the organization in order to provide scientific input for new and established products/solutions and fulfill registration or regulatory requirements for effective market positioning
Provides expertise, training and guidance on clinical research
Oversees the project planning and execution of clinical studies, including DSM sponsored, partner sponsored, and investigator initiated trials
Guides and supports trial management activities including, budget management, study management, CRO/vendor oversight, risk mitigation and GCP
Identifies barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics
Assures compliance with all regulatory requirements associated with clinical research
Collaborates with crossfunctional teams (HNC Global R&D Center, Science Translation & Advocacy and other key units) to provide and clinical operations support as needed
Ensures proper communication with internal stakeholders (e.g. Marketing, Innovation, R&D, Science Translation & Advocacy, BD&T etc.) and external stakeholders (e.g. CROs, vendors, B2B customers of DSM and their respective customers /B2C/).

We bring

Sciencebased corporate environment that is constantly looking for innovative new solutions
A dynamic work environment with many challenges that give you the possibility to work autonomously and with a team in finding the right solutions
The chance to move along and develop yourself in constantly growing industry and to make a difference for our stakeholders.

You bring

At least MSc degree in Life Sciences or equivalent, with qualification in clinical trials
10+ years of applied experience in clinical research, incl. clinical operations (practical experience in the management of clinical trials as a project manager or other relevant experience at a pharmaceutical/biotech company or CRO)
Expert knowledge of ICH/GCP guidelines
Knowledge & interest in nutrition science, industry insights, business acumen
Proficiency in relationship building
Proven project, portfolio, partnership and team management skills
Demonstrated ability to manage multiple clinical studies simultaneously
Excellent writing, communication, and presentation skills
Maintain appropriate professional licenses and certifications.

About our team

DSM Nutritional Products - Health, Nutrition & Care is a business group focused on developing and supplying health, nutrition & care solutions for multiple customers.

Innovation leadership, product quality, supply reliability & flexibility to meet customer demands are key success factors to reach our HNC business objectives.

As part of this goal, the building & leveraging of human evidence through clinical research for our customers & consumers are key deliverables.

How to apply
Royal DSM is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, or any other charac