Director of ADME
Our client, a global pharmaceutical company with one of the strongest pipelines in the Pharmaceutical industry is looking to bring on board a subject matter expert in ADME/DMPK, as a Director of ADME at their Cambridge HQ.
The Director of ADME has accountability for all non-clinical DMPK in our client’s Innovative Medicine Oncology portfolio from early discovery through to launch and life cycle management. They are looking for a senior leader who has a passion for and expertise in DMPK science, applied to Cancer biology, with the experience of working in both drug discovery and development.
The Director of ADME leads a team of ~10-12 individuals which collectively provide Oncology projects with experimental DMPK data, information and knowledge to build an understanding of the DMPK properties of a compound. In drug discovery this drives design strategies towards an optimal clinical candidate and prediction of clinical pharmacokinetics, efficacious and tolerable dose/schedules and drug-drug interaction profile. In drug development establishment of ADME properties enable clinical evaluation, assist dose and schedule setting, identify risks in patient populations, inform product labelling and ultimately support launching clinically meaningful drugs to patients. The Associate Director/Director of ADME has expert and broad DMPK knowledge and provides overall functional input into project teams. The individual will be an internationally recognised expert in DMPK with a strong scientific reputation and publication track record.
The role holder will:
• Line manage a range of senior and junior colleagues who are accountable for high quality, impactful experimental DMPK data including metabolite identification, PK-PD bioanalysis and non-routine bespoke in vitro ADME data including that related to drug metabolising enzyme and transporter mediated drug-drug interactions.
• Act as a DMPK scientific leader to work with internal and external partners that produce standard design experimental in vitro and in vivo ADME data.
• Act as a DMPK scientific leader of in silico predictive DMPK strategies using artificial intelligence together with internal and external partners.
• Act as the Oncology IMED scientific leader of physiological based PK and DDI simulation approaches including leading the use and development of SimCYP software and consortium membership, together with the client's partner functions.
• Act as a DMPK functional leader for Oncology projects from discovery through development to life cycle management.
• Possesses specialist knowledge in the DMPK area and is seen as a source of reference. Recognised as an ADME expert via, a strong publication record, providing solutions that are highly innovative to tasks on difficult drug projects and unusually scientific complex problem. Will lead projects and be responsible for training and developing others. Contributes to business development and will influence strategic direction.
• To be part of the Oncology DMPK leadership team department ensuring that state of the art DMPK science is applied broadly and consistently across drug discovery and development to support compound design and project progression.
• Lead global teams and work streams related to DMPK sciences across the client's 3 main therapy areas.
• May also act as a DMPK project leader for Oncology Discovery and/or Development Projects.
▪ Deliver the preclinical and translational DMPK work package in projects from target validation/lead identification to launch and life cycle management.
▪ Design preclinical studies and report results to Discovery project teams to evaluate and optimise series and compounds towards a selected candidate with acceptable predicted clinical PK properties and drug-drug interaction profile.
▪ Provide expert technical direction, challenge and problem solving in projects.
▪ Contribute to and review the non-clinical DMPK part of regulatory documents (e.g. IND, IMPD, IB, NDA)
▪ Work collaboratively with other scientists including Clinical pharmacologists, bioscientists and translational scientists to ensure an adequate forward and back translation of PK, PKPD data and models.
▪ Publish peer reviewed papers and reviews in internationally recognised journals.
▪ Provide disciplinary scientific leadership, coaching and mentorship for less experienced scientists.
▪ Identify leading improvements in science and technologies that can be successfully applied to a highly competitive drug discovery or development process that contributes to achievement of Business goals.
▪ Recommend, gain commitment to, initiate, lead and champion new science and technology initiatives to improve DMPK science capability to deliver IMED projects.
▪ Lead scientific discipline networks and act as a focus for debate within the science community
▪ Supervise student and Post Doc programmes.
▪ Lead external collaborative projects with academic or cross-pharma pre-competitive groups
▪ Ensure compliance with corporate code of conduct guidance, best practice SHE and Good Laboratory Standards.
• Candidate would have a Ph. D. or equivalent in relevant scientific discipline, pharmacology, pharmaceutical sciences, with several years of relevant experience in drug discovery and development.
• The individual should possess at least 10 years of relevant experience in DMPK with several years of experience in Oncology drug discovery and development.
• Extensive experience of drug discovery and development projects including experience as core team member and good understanding of other disciplines
• The person should have an international reputation within a DMPK related discipline and will be routinely publishing and presenting in external fora.
Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: email@example.com . We endeavour to come back to you within 24 hours of CV submission.