Preclinical Manager

a global biotech company is looking for Preclinical Manager

The role definition is to oversee and manage preclinical development activities, supporting development program from early stages to clinical development and regulatory approvals.

Responsibilities:

Develop and implement strategic plans for preclinical development, aligning with the overall development goals of the company. Identify key milestones, deliverables, and timelines.

Design and oversee preclinical studies, including pharmacology, toxicology, and safety assessments, to evaluate the efficacy and safety of medical devices. Collaborate with internal and external stakeholders to ensure high-quality study execution.

Lead the in vitro studies by demonstrating background in biology and molecular biology including tissue culture systems, protein biochemistry immunoassays.

Ensure compliance with relevant regulatory guidelines and requirements, such as Good Laboratory Practices (GLP) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and ISO (international organization for standards) standards. Prepare preclinical sections of regulatory submissions.

Analyze preclinical data, interpret results, and provide comprehensive reports to support decision-making.

Collaborate with cross-functional teams, including research, clinical development, regulatory affairs, and project management, to facilitate a seamless transition from preclinical to clinical development.

Select, lead, and manage ongoing communication with preclinical local and international Contract Research Organizations (CROs).

Qualifications and Skills

Ph.D./MSc in Biology, DVM, in a relevant scientific discipline (e.g., pharmacology, toxicology, biochemistry) with a solid understanding of medical device/drug development processes.

Minimum 5 years of industry experience in preclinical development within the pharmaceutical or medical device industry.

Strong understanding of regulatory guidelines and requirements governing preclinical development (e.g., GLP, ICH, ISO).

Team management skills.

Create relationships with internal and external partners.

Strong problem-solving and decision-making skills, with the ability to prioritize tasks and manage multiple projects simultaneously.