Your impact

We are seeking a highly motivated and experienced Director of Clinical Pharmacology to lead clinical pharmacology strategies for oncology and non-oncology small molecule programs.

Reporting directly to the Head of Early Development, you will serve as a key member of the Clinical Development team. In this highly visible and critical role, you will be the single point of accountability for all clinical pharmacology activities. You will independently launch, execute, and manage clinical pharmacology plans to support global clinical trials conducted in partnership with Clinical Research Organizations (CRO's). Furthermore, you will have the opportunity to collaborate with preclinical development and leverage pharmacokinetic (PK) data into human dose models for ensuring optimal efficacy and safety in the clinic. You will use the latest technologies, including predictive artificial intelligence (AI) models to innovate and deliver quality clinical packages.

What you will do

Clinical Pharmacology & Bioanalysis:

• Strategic Leadership: Design, independently launch, and execute comprehensive clinical pharmacology, bioanalysis, and modeling / simulation strategies for small molecule oncology and non-oncology programs from Phase 1 through late-stage development.
• CRO Management: Oversee and partner with global clinical CROs to ensure the high-quality, timely, and cost-effective execution of clinical pharmacology studies and human bioanalysis and PK data analyses within broader oncology and non-oncology clinical trials.
• Study Design & Execution: Lead the clinical pharmacology components of Phase 1 and 2 clinical protocols, including dose-escalation strategies, dose-rationale, PK sampling schemes, Food-Effect, and drug-drug interaction (DDI) assessments.
• Data Analysis: Direct the analysis, interpretation, and reporting of bioanalytical PK data from clinical trials and human AME (mass balance) studies; utilize appropriate modeling approaches (e.g., PopPK, exposure-response) to inform dose optimization and the recommended phase 2 dose/schedule (RP2D) selection for pivotal studies.
• Regulatory Agency Interactions: Author and review human clinical pharmacology and biopharmaceutics sections for regulatory documents, including INDs/CTAs, Investigator Brochures (IBs), clinical study reports (CSRs), and NDA/MAA filings. Represent the company in regulatory authority meetings.

Use of Innovative Technology: Leverage predictive AI models to enable data automation and deliver quality clinical packages on accelerated timelines, including predictive human PK and DDI tools.

Translational Pharmacology:

• Capability Building: Help advance human PK and translational capabilities, including human efficacious dose optimization to support the early clinical development pipeline.
• Translational Modeling: Utilize mechanism-based PK modeling, allometric scaling, and/or Physiologically Based Pharmacokinetic (PBPK) modeling to predict human clearance, efficacious doses, exposure, and therapeutic windows.
• Pipeline Advancement: Provide strategic input to help identify developable drug candidates and transition them smoothly into First-in-Human (FIH) Phase 1 trials.
• Use of Innovative Technology: Leverage predictive AI models to enable data automation and deliver quality data packages on accelerated timelines, including predictive human PK and DDI tools.

Skills and qualifications
Essential:

• Education: Ph.D. or Pharm.D. in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a closely related discipline.
• Experience: 8+ years of relevant biopharmaceutical industry experience, with a track record of strategic leadership.
• Therapeutic Area Expertise: A deep understanding of both oncology and non-oncology drug development, including Phase 1 dose-escalation and registrational trial designs and the specific nuances of small molecule targeted therapies.
• Translational & Technical Skills: Demonstrated ability to translate in-vitro and in-vivo data into human PK and dose predictions. Hands-on experience with, or strong ability to oversee vendors using modeling tools like NONMEM, GastroPlus, or Simcyp. Leverage predictive AI models, including predictive human PK and DDI.
• Vendor Oversight: Experience selecting, managing, and independently collaborating with global CROs and external vendors.
• Regulatory Experience: Proven track record of authoring clinical pharmacology sections of regulatory submissions (IND, NDA) and interacting with global health authorities (FDA, EMA).

Attributes:

• Ability to work independently and operate effectively in a fast-paced, lean, and agile environment.
• A strong enthusiasm for operating in an AI-first environment and leveraging cutting-edge automation in daily workflows.
• Strong cross-functional collaboration skills, with the ability to influence and communicate complex scientific concepts to diverse teams (Discovery, Clinical, Regulatory).
• Entrepreneurial mindset with a willingness to "roll up your sleeves" to build capabilities from the ground up.

Culture and values

We are guided by our shared values. It's not about finding people who think and act in the same way. These values help to guide our work and will continue to strengthen it.

ThoughtfulThoughtful at Iso is about curiosity, creativity and care. It is about good people doing good, rigorous and future-making science every single day.

BraveBrave at Iso is about fearlessness, but it's also about initiative and integrity. The scale of the challenge demands nothing less.

DeterminedDetermined at Iso is the way we pursue our goal. It's a confidence in our hypothesis, as well as the urgency and agility needed to deliver on it. Because disease won't wait, so neither should we.

TogetherTogether at Iso is about connection, collaboration across fields and catalytic relationships. It's knowing that transformation is a group project, and remembering that what we're doing will have a real impact on real people everywhere.
Creating an extraordinary company

We believe that to be successful we need a team with a range of skills and talents. We're building an environment where collaboration is fundamental, learning is shared and every employee feels supported and able to thrive. We value unique experiences, knowledge, backgrounds, and perspectives, and harness these qualities to create extraordinary impact.

Hybrid working

It's hugely important for us to share knowledge and build strong relationships with each other, and we find it easier to do this if we spend time together in person. This is why we follow a hybrid model, and would require you to be able to come into the office 3 days a week (currently Tuesday, Wednesday, and one other day depending on which team you're in). If you have additional needs that would prevent you from following this hybrid approach, we'd be happy to talk through these if you're selected for an initial screening call.