A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Clinical Trial Management is responsible for the strategic and tactical operational delivery and execution of all R&D sponsored global programs in Phase I - Phase IV.
We are seeking an influential, fearless and disruptively innovative leader who is looking for the opportunity to evoke change and drive accelerated performance in a highly visible role and fast paced environment. This appointment would sit as part of a growing leadership team responsible for driving the operational strategy and tactical execution of all global programs and trials within R&D.
The Head of Biosample Operations is accountable for developing and driving biosample operational strategy across all therapeutic areas and working collaboratively with cross functional therapeutic team leaders in R&D. This role is accountable for PK/immunogenicity clinical assay outsourcing and oversight, as well as clinical biomarker sample management, biomarker data management and biobanking. This role is accountable for coordinating operational activities along the value chain to ensure appropriate collection (incl. patient informed consent), delivery, and analysis of bio-samples globally with the highest standards of quality, ethics, and regulatory requirements. In addition, responsibilities include establishing and improving global translation medicine business process while cultivating a positive, collaborative, agile, and development-oriented team and culture. The Biosample Operations team will liaise with external assay laboratories, collaboration partners and CROs. This position reports to the Head of Clinical Trial Management and works collaboratively across study teams and associated target groups to ensure planning, execution and data delivery of the biosample strategy for clinical trials conducted by Merck KGaA, Darmstasdt, Germany.
Who you are:
A strong and accomplished leader who is able to drive, develop and lead teams. An individual who can guide, energize, influence and motivate people. Someone who can understand and provide input into overall translational medicine strategy, setting operational strategy for sample operations & biobanking. Someone who has excellent written and verbal communication skills; able to swiftly build trust-based relationships with internal and external contact persons. Has excellent budget and situational negotiation and conflict management skills. Strategic thinking and analytical skills, quick assessment and excellent judgment; able to identify risks and problems, to develop innovative problem-solving strategies even in complex situations, and to take appropriate measures when required. Novel thinking beyond own function; is familiar with and takes into account overall business objectives and company corporate strategy.
- Bachelor’s degree with 12+ years of experience, in clinical and drug development in the pharmaceutical/biotech/CRO industry
- 5+ years of experience in clinical laboratory and biosample management
- Significant experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
- Track record of building a new team and capability and implementing a strategic vision in-line with the corporate vision on translational medicine
- Track record of innovative thinking & keeping abreast with latest developments in clinical research methodologies
- Demonstrated experience in collaborating with other functions in a complex matrixed organization
- Prior experience in leading a team, resource management, talent acquisition, developing employees and fiscal oversight of an Op Ex budget
- Industry recognized experience in Translational Medicine Operations (e.g., biosample management, CDx)
- Knowledge of ICH-GCP, other relevant Guidance documents (from ICH, FDA, EMEA etc.), and
of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries
- Strong project management skills, willing to take on and build efficient business processes, able to identify risks and implement mitigation strategies
- Strong communication skills, both written and verbal
- Extensive industry network in Translational Medicine areas
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com