Senior Manager – Preclinical Development (m/f/d)
OncoOne is a biotech startup dedicated to developing innovative therapeutics to treat patients with solid tumors. OncoOne is an equal opportunity employer that maintains a diverse and inclusive work culture.
We are seeking a highly motivated and creative Preclinical Development Manager who will design, oversee, and manage preclinical in vivo studies for new biotherapeutics in the field of oncology, as performed by external subcontractors. This includes early efficacy/PK/PD studies, as well as studies aimed at fulfilling regulatory submission criteria.
Duties & Responsibilities
- Lead the development of scientific in vivo strategies on drug discovery programs
- Independently design and conduct in vivo studies to evaluate and establish efficacy/PK/PD relationships
- Evaluate and select CROs or academic institutions for the implementation of preclinical studies
- Design protocols for in vivo preclinical toxicology studies according to EMA/FDA requirements
- Ensure that projects have all critical in vivo data in place to enable project stage dependent decisions
- Contribute to filing documents by writing and approving relevant in vivo sections of stage gate reports and regulatory documents
- Assist with the integration of initiatives (e.g. biomarker plans, indications, etc.) with management, drug discovery scientists, and external experts
- Write grant applications, patent applications and scientific publications
- Present data reports and results to management, Scientific Advisory Board, investors, and other stakeholders
- PhD in relevant life science discipline (cancer biology, immunology, pharmacology) with ≥ 5 years of industrial experience in the preclinical studies sector, including regulatory submission-aimed preclinical development studies
- Demonstrated expertise in developing focused in vivo strategies and utilizing efficacy/PK/PD data to drive lead optimization & characterization of biotherapeutics as well as translational strategies to enable early clinical development
- Solid understanding of biologic drug development process is mandatory
- Scientific focus on preclinical research in oncology/immunooncology is preferred
- Proven ability to apply pharmacological principles to the preclinical phase of drug development
- Knowledge of the GLP requirements for nonclinical pharmacology/toxicology
- Strong communication and interpersonal skills
- Ability to work flexibly in a dynamic and collaborative environment
- Proficient English language skills
- Self-motivated, open-minded and innovative team player with collaboration and problem-solving skills
For the position we offer at least an annual gross salary of EUR 70.000,-. The actual remuneration package will be based on your professional experience, qualification and skills. Increased pay is possible.
Please send your cover letter and resume to firstname.lastname@example.org
We look forward to receiving your application!