Associate Director R&D Biotech

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 important international venture capital that is active across the entire value chain of life sciences investments, from seed to later-stage, with a focus on 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.