Director of Clinical Pharmacology, Cambridge, MA

Isomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease. The future is coming—a future enabled and enriched by the power of machine learning, where diseases are curtailed or cured through better and faster drug discovery. Join an interdisciplinary team driving groundbreaking innovation and play a meaningful role in achieving our ambitious goals while being part of an inspiring and collaborative culture.

About Isomorphic Labs

Isomorphic Labs (IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Our interdisciplinary team of drug discovery experts and machine learning specialists has developed powerful predictive and generative AI models that accelerate scientific discovery at digital speed. Our name reflects the belief in an underlying symmetry between biology and information science. By harnessing AI, we model complex biological phenomena to design novel molecules, anticipate drug performance, and develop innovative medicines for some of the world’s most devastating diseases.

We have built a world-leading drug design engine comprising AI models capable of working across multiple therapeutic areas and drug modalities. Our technology transforms how new drug candidates are designed, bringing potential medicines to patients faster. Since our founding, we’ve grown a world-class team led by founder and CEO Sir Demis Hassabis and President Max Jaderberg, establishing strategic collaborations with partners including Eli Lilly, Novartis, and Johnson & Johnson. Our internal pipeline includes multiple programs in oncology and immunology, and we’ve raised over $2.7 billion in funding to scale our AI drug design engine globally.

Headquartered in London with offices in Lausanne, Switzerland, and Cambridge, Massachusetts, Isomorphic Labs is advancing internal candidate programs toward the clinic while working across modalities such as small molecules, molecular glues, peptides, and antibodies.

About the role

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 and 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 in partnership with Clinical Research Organizations (CROs). Additionally, you will collaborate with preclinical development teams to leverage pharmacokinetic (PK) data into human dose models, ensuring optimal efficacy and safety in the clinic. This role offers the opportunity to use cutting-edge technologies, including predictive AI models, to innovate and deliver high-quality clinical packages.

Responsibilities

• Clinical Pharmacology & Bioanalysis: Strategic Leadership: Design, 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 high-quality, timely, and cost-effective execution of clinical pharmacology studies, human bioanalysis, and PK data analyses within broader 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 modeling approaches (e.g., PopPK, exposure-response) to inform dose optimization and 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: 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 identify developable drug candidates and transition them smoothly into First-in-Human (FIH) Phase 1 trials.

Requirements

• 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 in clinical pharmacology.
• Therapeutic Area Expertise: Deep understanding of both oncology and non-oncology drug development, including Phase 1 dose-escalation, registrational trial designs, and the 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. Experience leveraging predictive AI models, including predictive human PK and DDI tools.
• Vendor Oversight: Experience selecting, managing, and 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.
  • Strong enthusiasm for operating in an AI-first environment and leveraging cutting-edge automation in daily workflows.
  • Excellent 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, which strengthen our work and foster an environment of curiosity, creativity, and collaboration:

• Thoughtful: Curiosity, creativity, and care drive our rigorous, future-making science every day.
• Brave: Fearlessness, initiative, and integrity are essential as we tackle monumental challenges.
• Determined: Confidence in our hypothesis, urgency, and agility define our pursuit of solving disease.
• Together: Connection, collaboration across fields, and catalytic relationships remind us that transformation is a group effort with real impact on people everywhere.

We believe success requires a team with diverse skills, talents, and perspectives. We are committed to equal employment opportunities regardless of sex, race, religion or belief, ethnic or national origin, disability, age, citizenship, marital status, sexual orientation, gender identity, pregnancy, or any other basis protected by applicable law.

Schedule

Hybrid working model, with importance placed on sharing knowledge and collaboration.