Associate Director R&D Biotech

OrgPortunity; Roma; In loco; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading biotech company in Rome seeks an experienced professional to oversee and manage preclinical research and early development studies. The ideal candidate will have a degree in Life Sciences and substantial experience in pharmaceuticals, particularly in R&D project management and team leadership. This role offers an exciting opportunity to contribute to groundbreaking cardiovascular treatments and to work within a dynamic start-up environment.

Competenze

• 8+ years' experience in pharmaceuticals or GLP company.
• 10+ years’ experience in managing R&D projects.
• 5+ years’ experience managing R&D teams.

Mansioni

• Plan research and early preclinical development studies.
• Ensure study deliverables meet corporate objectives, timelines, and budget.
• Manage the selection and outsourcing of preclinical research studies.

Conoscenze

Attention to detail

Time management

Organizational skills

Excellent communication

Formazione

Degree in Life Sciences (Molecular Biology, Genetics, Computational Biology)

Descrizione del lavoro

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.