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In the preclinical development team we are seeking an experienced
MANAGER PRECLINIAL DEVELOPMENT
to join our growing team and work from our office in Leiden.
The manager primary responsibility is to centrally manage all activities required for the effective design, execution, and completion of nonclinical toxicology and safety studies conducted with contract research organizations (CROs) for Leyden Labs drug development programs. The activities include but are not limited to: study planning and contracting, developing the protocol to maintain the overall study objectives, coordinating test material transfer and principal investigator activities, ensuring adherence to the protocol, monitoring via site visit/email/telephone, managing and reviewing study documents/data, finalizing the study report and archiving the study files.
For Good Laboratory Practice (GLP)-regulated studies, the manager will ensure compliance with the appropriate and current GLP regulations. The manager will directly support regulatory submissions (IND/CTA, NDA/BLA/MAA, IB, etc) by providing study reports, contributing to the written and tabular study summaries.
In this role, you will also interface with functional groups across the Leyden Labs organization to coordinate the activities and will work closely with preclinical development, laboratory groups, manufacturing, quality, legal, procurement etc. to provide the appropriate nonclinical support and expertise.
Responsibilities
- Manages outsourced nonclinical nonclinical toxicology and safety studies conducted with contract research organizations (CROs) as the sponsor representative and key external relationship manager
- Ensuring that the study conduct, record keeping, reporting and timelines are consistent with the study protocol
- Ensure that studies are compliant with the appropriate GLP regulations, Leyden Labs animal welfare policies, CRO standard operating procedures, and all relevant international regulatory guidelines
- Responsible for resolution of study related issues, interaction with internal experts and informing the appropriate people in a timely manner
- Ensure for timely and accurate transfer of study drug, study samples, data, and documents between internal and external collaborators
- Independently review and apply scientific literature, his/her own scientific knowledge
- Provide regular study updates
- Participate in GLP audits and external technical evaluations of CRO facilities.
- Independently prepare regulatory written and tabular summaries and assist in the review of various regulatory documents and summaries.
- A minimum of a BSc, MSc in a life sciences discipline;
- At least 3-5 years’ of work experience for a pharma or biotech company managing pre-clinical projects internally or externally;
- Experience in managing safety and toxicology studies outsourced at CROs
- Other routes into the role are possible
- Proficient knowledge of regulatory and international standard guidelines (e.g. GLP, OECD, etc)
- Excellence communicator, strong team player, and high level of logistical / planning ability
- Ability to travel 10-15%
What we offer:
- A challenging position (32-40 hours/week) in a dynamic scale-up biotechnology company
- Competitive pay and benefits
- Contribute to the development of next generation medicines providing protection against airborne viruses
- A stimulating working environment with an enthusiastic team
- Attention and possibilities for personal and professional growth
The team works a hybrid on-site schedule, and 3-4 days on-site in the office are required. Ideally our new colleague starts November 2024 but we are willing to wait for the best candidate, so we understand you have a notice period or already planned your annual leave.
This position is open to candidates currently residing in the Netherlands or willing to relocate to the Netherlands with an existing EU work authorization.
We are an equal opportunity employer, so we firmly believe in the added value of a diverse and inclusive group of people with one common goal. We are looking for people who can make an impact and work on a purpose, together.
