Mirobio is currently seeking a highly skilled and motivated professional to lead the Preclinical Research Department efforts supporting our portfolio of therapeutic monoclonal antibody therapeutics.
The successful candidate will be responsible for design and implementation of preclinical drug development plans supporting CTA and investigational New Drug (IND) applications. Additionally, this position will develop and validate bioanalytical methods used pre-clinically, and potentially clinically, to conduct antibody redistribution studies, and determine pharmacokinetic (PK) parameters used to analyse PK/PD relationships. The Director/Senior Director of Preclinical Sciences will also be responsible for identifying, auditing and managing preclinical studies in the areas of PK, toxicology, CMC and bioanalytical efforts conducted at contract research organizations (CROs). The postholder will have a thorough understanding of immunopathology and experience in biomarker discovery and validation.
Qualified candidates will be creative and detail-oriented with a passion for drug discovery, possess excellent project management, time management, communication, data analysis, and interpersonal skills, along with an overall understanding of, and direct hands-on experience, in early-stage development within the biotech/biopharma industry.
- Lead the development of preclinical data packages supporting regulatory submissions including preclinical study reports
- As part of R&D leadership team responsible for preclinical activities
- Lead a team of scientists (direct reports and through matrix management) to develop or access model systems and cell assays to demonstrate the preclinical activity and safety of drug candidates
- Identify and work closely with third party vendors to ensure that all elements of therapeutic development are optimally progressed.
- Collaborate with other Gilead departments on internal/external preclinical activities such as GLP and non-GLP safety studies, PK and biodistribution and bioanalytical and CMC supporting studies
- Design and implementation of novel biomarker assays, based on thorough literature review, to support the development of therapeutic antibodies in autoimmune diseases
- Act as project lead for multiple drug discovery projects
- Provide immunological expertise/guidance on the translational research aspects of drug projects
Qualifications and experience:
- PhD in immunology, pharmacology or related subject with 8+ years of relevant experience, at least 5+ years of experience specific to project management of preclinical/translational development of biotech/biopharma products
- Appreciation for and understanding of regulatory concerns related to biologic drug development
- Experience setting strategic direction for research group or department
- Experience in drafting and/or reviewing of the relevant sections and individual reports to support regulatory filing including pre-IND, IND, IB, and clinical lab manuals
- Strong familiarity with biotech/biopharma product development and stages of drug discovery
- Demonstrated knowledge of GLP regulations related to preclinical study planning and bioanalytical method development
- Proven experience selecting and managing CRO relationships
- Excellent problem solving, data analysis and computational skills
- Experience participating on cross-functional project teams
- Relevant technical skills to assess immune responses in health and disease
- Demonstrated ability to function independently and exercise high-level of judgement
- Excellent written and oral communication skills
- Excellent time management and multi-tasking skills
- Experience managing direct reports and project teams
- Self-starter with ability to tackle new problems learn new disciplines
- Able to demonstrate flexibility in a fast-paced dynamic small biotech setting
- 5 plus years of experience with biologics and validated evidence of taking biologics into the clinic
- Experience of antibody preclinical pharmacology
- Experience of developing therapeutics in autoimmunity, inflammation or immune oncology.
MiroBio is a start up company based on the Oxford Science Park. We are focused on developing biologics targeting immune checkpoint receptors.
For more information on MiroBio: www.mirobio.com
The company was recently acquired by Gilead Sciences, and is Gilead’s first international research site: https://www.mirobio.com/news/