Director - Regulatory Affairs & Clinical Development
Job ID 1011
We are a young and rapidly-growing company, solving tough problems with creative solutions as we work to bring better therapies to patients. One of these challenges is to build a rapid response platform capable of developing field-ready medical countermeasures within 60 days of a viral outbreak. The goal of this four-year program, funded by the US Defense Advanced Research Projects Agency (DARPA), is to deliver nucleic-acid encoded antibodies as prophylaxis against any viral disease, and will include first-in-human clinical trials performed during the course of the project. We are looking for an innovative and highly-collaborative scientific leader to drive the strategic planning, preclinical and clinical development required to realize this ambitious goal.
We want to hear from you if you have deep scientific expertise and a demonstrated record of outstanding contributions to translational science, specifically biologics. We’re looking for someone with not only an in-depth knowledge of regulatory requirements and project planning, but also with strong leadership skills and the ability to collaborate, lead, motivate and influence others.
How you might spend your days:
- Working collaboratively to plan a path from discovery through validation to clinical implementation
- Liasing with external partners, designing experiments and reviewing results
- Communicating with collaborators and consortium members, attending key meetings and conferences
- Contributing to the generation of investigator brochures, IND applications, clinical protocols and other regulatory documents, participating in conversations with key stakeholders and regulatory agencies
- Functioning as a scientific thought leader inside and outside the company
Preferred qualifications and experience:
- PhD in Biotechnology, Immunology, Cell Biology, Pharmacology, Biochemistry or in a field related to the responsibilities
- At least 5 years of experience in development of therapeutics in the pharmaceutical or contract research industries
- Experience driving projects from discovery through early clinical development
- In depth knowledge of GMP, GLP, and safety guidelines as well as of Canadian and US regulatory processes
- Experience with design and analysis of in vivo pharmacokinetic, pharmacodynamic and drug efficacy studies
- Experience with drug formulation, process development and manufacturing related to biologics
- Familiarity with engaging and managing external efforts with contract research and manufacturing organizations, and academic collaborators
- Ability to analyze complex third party data, troubleshoot, take initiative, evaluate quality of execution and follow through on projects
- Excellent leadership, communication, interpersonal and organizational skills
- Ability to listen effectively, promote discussion, and facilitate problem solving
Offers & benefits:
- The opportunity to work with and support an inspired team on challenging problems that matter
- An attractive compensation package, including health and lifestyle benefits
- A minimum of 3 weeks’ vacation
- A seat in our beautiful new office in Vancouver, BC, Canada
- Opportunities for personal and professional development
- Full time, permanent position
- Language of work: English
At AbCellera, we’re solving tough problems and creating innovative solutions from the ground up - custom immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - revolutionizing how our scientists can explore antibodies and the scale at which they can do it. This is life-changing research and you could be a part of it.
You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. We’re a growing company with a high-throughput pipeline and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of visionaries and innovators. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success, and we’re looking for someone like you to join us.
Please send us your application through our website and refer to Job ID 1011 in your cover letter. We apologize in advance but we receive a large volume of applications and are only able to contact those who are selected for an interview.