Head of Clinical Operations
vor 8 Monaten
In this role, you will ensure positive impact on people’s health and our 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 goal to improve human health.
Within the Health, Nutrition & Care is a business group, you will be accountable for delivering the clinical pipeline through leadership in clinical operations. Furthermore, it is responsible for ensuring clinical trials follow the company’s procedures, external regulations, and any other applicable regulatory and ethical requirements.
At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.
**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.
- Provide leadership in the development of the clinical trial management. Lead, coach and develop 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.
- Ensure 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)
- Oversee the project planning and execution of clinical studies, including DSM sponsored, partner sponsored, and investigator-initiated trials.
- Guide and supports trial management activities including, budget management, study management, CRO/vendor oversight, risk mitigation and GCP.
- Identify barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics.
- Ensure proper communication and collaboration 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**
- A rich history and a promising future of bold scientific innovation and passionate creation with our customers.
- A space to grow by encouraging and supporting curiosity and an open mindset.
- A culture that prioritizes safety and well-being, both physically and mentally.
- The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose.
- A flexible work environment that empowers people to take accountability for their work and own the outcome.
- An eagerness to be one team and learn from each other to bring progress to life and create a better future.
**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
- Demonstrated ability to manage multiple clinical studies simultaneously.
- Maintain appropriate professional licenses and certifications.
**Equal opportunities commitment**
dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate, there’s a place for everyone at dsm-firmenich.
dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilitie
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