Director (or Senior Director) Non-Clinical PK/PD
Vor 2 Tagen
A leading biotech company is seeking an experienced and highly motivated scientist to lead PK/PD activities within its Non-Clinical Development (NCD) team. This role offers the opportunity to make an immediate impact on the development of a growing pipeline of novel therapies by contributing expertise to both project teams and broader strategic discussions. As a small company, this role combines leadership with hands-on experimental design and execution, in collaboration with consultants and CRO partners.
Responsibilities:
- Design and implement integrated non-clinical PK/PD strategies from research through early clinical development.
- Work within cross-functional teams to align non-clinical DMPK activities with program objectives.
- Design and execute PK/PD studies for first-in-human trials, ensuring high-quality and timely delivery.
- Analyze, summarize, interpret, and report PK/PD study results.
- Develop PK/PD optimization strategies, ensuring appropriate exposure for preclinical safety testing and supporting human dose predictions.
- Oversee non-clinical sections of regulatory documents and reports.
- Ensure compliance with regulatory requirements and represent the non-clinical development function in health authority interactions.
- Manage and monitor external CROs and consultants.
- Stay current with developments in the field.
Qualifications:
- PhD in Pharmaceutical or Life Sciences with 5–10 years of relevant industry experience in non-clinical development.
- Proven track record in advancing biotherapeutic candidates from research through IND submission.
- Strong experience with therapeutic proteins, PK/PD, and safety principles of biotherapeutics.
- Familiarity with GLP regulations and experience in regulatory submissions.
- Expertise in immuno-oncology; additional experience in cardiometabolic diseases is a plus.
- Ability to design, interpret, and report PK/PD studies.
- Experience working with CROs and external consultants.
Personal Skills:
- Motivated with a can-do attitude, thriving in a dynamic and fast-paced environment.
- Proven ability to build effective relationships with internal and external stakeholders.
- Strong leadership, communication, and interpersonal skills.
- Good planning skills and ability to deliver on timelines.
- Capable of working independently and as part of a team.
About the Company: This pioneering biotech company focuses on developing innovative therapies in oncology and other therapeutic areas. With locations in Europe and the US, it combines chemical synthesis, protein engineering, and recombinant technology to create new treatments. The company offers a competitive salary, equity, modern office and lab facilities, and a supportive, inclusive work culture. Diversity and equality of opportunity are highly valued, and applications from all backgrounds are encouraged.
Seniority levelDirector
Employment typeFull-time
Job functionBusiness Development, Strategy/Planning, and Design
IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Research Services
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