The Role

As a Bioanalysis/Clinical Pharmacology Lead, you will play a pivotal role in advancing our ground breaking therapies from the lab to the clinic. Your expertise will drive the development of innovative bioanalytical strategies and contribute to the success of our clinical programs. You will join our expanding Development team at Alchemab with ambitions to sustainably develop multiple candidates to progression in the clinic. You will have a strong background in clinical development of biologics, along with successful prior experience working with external CROs and internal science partners to deliver bioanalytical packages that feed into Clinical Pharmacology decision-making.

The opportunity spans multiple therapeutic areas and involves working with cross-functional multidisciplinary teams. The Bioanalysis/Clinical Pharmacology Lead’s main role is in the strategy and implementation of innovative PK/ADA assay development and validation, critical reagent design, and sample analysis within clinical studies and is expected to serve as a key member of development project teams for Clinical planning of clinical stage assets. Having a good understanding of PK and immunogenicity, along with basic pharmacology principles, the candidate has the opportunity to expand their influence into pre-clinical PK data analysis/ interpretation, and additional clinical pharmacology work, such as model informed drug development, with key CRO partners.

Responsibilities

• Membership of project development teams and clinical trial teams
• PK/ADA assay development, validation and execution to support multiple simultaneous projects to the clinic
• Appropriate use and promotion of innovation for leadership in bioanalytical assay design and process
• Interactions with external providers for assay transfer and sample analysis during study conduct
• Interaction with Research functions to promote bioanalytical and clinical pharmacology planning for appropriate ‘pull’ of projects from Research to Development phase
• Regulatory document contribution and authoring, Bioanalysis regulatory awareness

Functional Leadership & Talent Development:

This position will have responsibility for a small team (1-2 individuals), which will be scaled with the company as it grows.

• Recruit, retain, lead and develop a high-performing functional team, providing mentorship, coaching, performance management and professional development opportunities to support career growth and succession planning.
• Foster a positive and collaborative work environment that encourages innovation, creativity, and high performance.
• Foster a culture of diversity, equity, and inclusion that values and respects the contributions of every individual.

Essential

• Bring your previous experience to enhance our dynamic Development team:
  • PK bioanalysis of large molecule therapeutics (preferably monoclonal antibodies/LBAs/mass spectrometry analysis) and strong understanding of regulatory requirements
  • Experience of ADA assay development for large molecules (especially monoclonal antibodies) and knowledge of multiple strategies (such as bridging assays, SPEAD…)
  • Interaction/management of external consultants/contract research organisations and with a record of strong multifunctional internal scientific collaboration

Desirable

• Basic PK computational analysis to a level able to provide basic PK parameters and early assessment for Research and pre-clinical stage projects to enable project progression
• Understanding of the impact of and ability to influence model informed drug development

Qualifications

• PhD in a relevant Life Sciences/chemistry discipline plus relevant experience in Bioanalytical area in a biotech or pharma environment, or Relevant Life Sciences/Chemistry Degree plus equivalent relevant industry experience

NOTE: This job description is not intended to be all inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organisation.

Note to recruitment agencies: we are not looking for assistance at this stage so please contact the HR department only at hr@alchemab.com if you think you can help in the future.