Affivant Sciences: Senior Director Non-Clinical Pharmacology (f/m/d)

Location: Roivant Sciences GmbH, Viaduktstrasse 8, 4051, Basel, Switzerland

Affivant Sciences, a wholly owned subsidiary of Roivant, is dedicated to developing the next generation of immuno-oncology treatments by harnessing the untapped potential of the innate immune system to fight cancer. Our innovative bi-specific innate cell engagers are designed to target specific patient populations as powerful monotherapies and combination treatments. The technology platform which generated our bi-specific innate cell engagers has already been clinically validated. The long-term vision for Affivant is to successfully develop a pipeline of disruptive immuno-oncology solutions to tackle cancers with high unmet medical need.

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014 Roivant has achieved the following critical milestones: launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 successful phase 3 readouts since 2019. Traditionally, Roivant provides all the capital required for Vant operations until the Vant becomes a public company. Roivant attracts, retains, and motivates entrepreneurial company builders that have deep domain expertise with competitive compensation and benefits, including stock option grants in the Vant.

For our headquarter office in Basel, we are looking for a Senior Director Non-Clinical Pharmacology.

The Senior Director Non-Clinical Pharmacology will be responsible for evaluating the non-clinical safety & toxicology, ADME/PK, and immunogenicity profiles of Affivant’s oncology R&D pipeline. They will play a critical role in the R&D team, aggregating non-clinical experience and bioanalytical knowledge with input from functional leadership to formulate strategy that will support the development of investigational drugs through to registration.

Responsibilities:

  • Plan, execute and monitor non-GLP and GLP toxicology studies in partnership with CROs (contract research organizations).
  • Plan, execute and monitor bioanalytical assay (PK, immunogenicity, receptor occupancy etc) development, validation, and testing in partnership with CROs.
  • Directing/executing non-clinical activities up to IND including PK/PD data analysis and interpretation from animal models, TK evaluation; recommend the starting dose in FIH trials based on allometric scaling or physiologically based PK modelling.
  • Leading and ensuring selection of dosing regimen for nonclinical studies and FIH studies during the pre-IND stage.
  • Identify, evaluate, and select CROs to run studies, including site visits and sponsor audits as required.
  • Review study reports and compile non-clinical sections of regulatory documentation (e.g. Investigator Brochure, pre-IND, IND and regulatory briefing documents).
  • Interact with regulatory agencies (responses to queries, preparation of pre-meeting documents, attend teleconferences and meetings with Health Authorities, as needed).
  • Continually review and monitor guidance, regulations, and publications relevant to non-clinical development with a specific focus on biologics and oncology.
  • Identify and work with expert consultants depending on project-specific needs.

Requirements:

  • PhD in related Life Sciences discipline with background in immunology and/or oncology
  • 10 years + pharmaceutical industry experience in bioanalysis and non-clinical safety/toxicology
  • Previous experience working in a project team as a non-clinical safety assessment representative, interacting with other disciplines in the development team (e.g. Project Management, Translational Science, CMC, Clinical, Regulatory, etc.)
  • Experience writing the non-clinical portions of regulatory documents, and previous interactions with regulatory agencies
  • Demonstrated ability to work effectively in a cross-functional team environment
  • Proven ability to manage multiple projects/tasks simultaneously and to work independently in a fast-paced environment
  • Excellent written and oral communication skills
  • Excellent analytical skills with strong attention to detail, takes pride in high quality work
  • High ethical standards

Affivant Sciences is committed to fostering a diverse, inclusive environment and is proud to be an equal opportunity employer.

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