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Our client is a preclinical stage biotech company pioneering inhalable cardiovascular treatments via non-viral nano-delivery of biologics. The Company is a start-up devoted to the clinical development of an innovative proprietary platform for the tissue-directed delivery of therapeutic peptides and RNAs. The start-up is part of the portfolio of an international venture capital active across seed to later-stage investments in healthcare and sustainability. We invite you to take a look at this career opportunity and consider building your promising future by becoming a member of the team!
Purpose of the position:
- Plan research and early preclinical development studies’ directions, goals, milestones as well as transition from drug discovery to proof of concept (POC) studies.
- Ensure that study deliverables meet corporate objectives, timelines, and budget.
Key Responsibilities:
- Ensure the selection of new drug candidates and define back-up strategies.
- Manage the selection and outsourcing of preclinical research and early development studies to contract research organizations (CROs) and scientific entities.
- Plan, monitor, analyze, and report preclinical research and early development studies, including review of related documentation, being the primary internal and external point of contact for preclinical research and early development projects.
- Manage development issues through close interaction with different groups (non-clinical development, Clinical Development, QA & Regulatory, etc.).
- Provide technical advice, support project teams (Regulatory Affairs, Non-Clinical and Clinical) and evaluate conclusions/impact on programs, indication selection, and clinical/regulatory strategy (including INN request).
- Provide technical input on bio analytics for non-clinical and clinical studies related to method definition, development and validation.
- Collaborate on the design of non-clinical investigative and pharmacology studies.
- Write/update the preclinical part of the regulatory documents (IND, IB, IMPD).
- Support patent management and act as a back-up company reference for IP.
- Manage the preparation and presentation of preclinical research and early development data for scientific meetings with the stakeholders.
- Preparation of and participation in internal and external scientific meetings and communication.
- Manage and supervise the research team.
Qualifications:
- Degree or equivalent experience in Life Sciences (Molecular Biology, Genetics, Computational Biology, cardiovascular) or related field.
- (PhD or Masters).
- 8+ years' experience in pharmaceuticals or GLP company.
- 10+ years’ experience in management of research & development projects.
- 5+ years’ experience managing R&D teams. Ability to work independently, outstanding attention to detail, time management and organisational skills are complemented by your excellent communication skills.
Seniority level
Employment type
Job function
- Research, Science, and Health Care Provider
- Industries
- Biotechnology Research, Pharmaceutical Manufacturing, and Nanotechnology Research
We’re removing barriers to knowledge sharing. This description is for candidate review and does not represent a job posting in itself.