Head of Clinical Operations

Isomorphic Labs•Cambridge, MA

5d•Hybrid

About The Position

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 incredible power of machine learning. A future in which diseases are curtailed or cured starting with better and faster drug discovery. Come and be part of an interdisciplinary team driving groundbreaking innovation and play a meaningful role in contributing towards us achieving our ambitious goals, while being a part of an inspiring and collaborative culture. The world we want tomorrow is the one we’re building today. It starts with the culture at this company. It starts with you. About Iso Isomorphic Labs (IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Since then, our interdisciplinary team of drug discovery experts and machine learning specialists has built powerful new predictive and generative AI models that accelerate scientific discovery at digital speed. Our name comes from the belief that there is an underlying symmetry between biology and information science. By harnessing AI’s powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world’s most devastating diseases. We have built a world-leading drug design engine comprising AI models that are capable of working across multiple therapeutic areas and drug modalities. We are continually innovating on model architecture and developing cutting-edge capabilities to advance rational drug design. Every day, and with each new breakthrough, we’re getting closer to the promise of digital biology, and achieving our ambitious mission to one day solve all disease with the help of AI. Your impact The experienced and visionary Head of Clinical Operations will lead the transition of our internal programs from discovery to IND to clinical-stage execution. Reporting to the Chief Medical Officer, this role will be the founding architect of our Clinical Operations function. Responsible for building the team, systems, vendor partnerships required, and leverage AI and emerging technologies to manage a large clinical portfolio with unprecedented speed and a high probability of success. This is a high impact leadership role for a leader who can bridge long-term clinical development strategy with the tactical excellence needed to meet immediate program milestones.

Requirements

Education: Bachelor’s in life sciences or related field; advanced degree or professional certification in a healthcare-related, scientific, or technical discipline preferred.
Experience: 15+ years in the pharmaceutical/biotech industry, with a proven track record in small to mid-sized startup environments, preferably with oncology or inflammation experience.
Track record: Expert at steering cross-functional teams through IND to clinical trials. Proven ability to align stakeholders to understand their critical roles and responsibilities in the transition from IND to clinical execution.
A high impact communicator with the ability to influence executive level decisions and represent the company to regulatory authorities.
Vendor agility: Extensive experience selecting and managing external vendors/CROs.
Regulatory intimacy: Deep knowledge of ICH/GCP and regulatory guidelines.
Leadership Effectiveness: Demonstrated success in building and mentoring high-impact Clinical Operations teams in a fast-paced, matrixed environment.
Strong interpersonal skills, conflict resolution, and negotiation skills in multifunctional matrixed and global environments.

Nice To Haves

The Builder: Experience scaling a Clinical Operations function from the ground up in a startup or small-biotech setting.
The Adapter: Ability to pivot seamlessly from high-level global strategy to hands-on tactical execution.
The Innovator: Knowledge of industry trends and technologies to reimagine traditional approaches, leveraging automation or digital tools to simplify workflows and accelerate the path to patients.

Responsibilities

Serve as the foundational architect for Clinical Operations, establishing the “fit for purpose” capabilities, infrastructure, SOPs, and GxP systems required to transition to a clinical-stage organization.
Operate at a strategic level to provide input into risk management, oncology and/or inflammation therapeutic area expertise, and long-range planning.
Serve as a subject matter expert, educating and collaborating with other departments to align clinical operations with overall company priorities.
Drive smart, lean execution through scenario planning, high-level forecasting, and clinical P&L management to maximize resource efficiency.
Drive the operational roadmap for the entire clinical life cycle, ensuring seamless execution from IND enabling studies through First-in-human (FIH), Proof of Concept (POC), and pivotal registration trials while maintaining rigorous oversight of clinical trial management, TMF, and data operations.
Track progress against milestones, providing regular updates to leadership and proactively identifying, resolving, or escalating issues that could impact timelines or budget.
Manage study start-up activities, including global feasibility, site selection, and contract negotiations, playing a hands-on role until the internal team is expanded.
Collaborate with cross-functional teams to develop Target Product Profiles (TPPs) , Clinical Development Plan (CDP), and study-specific documents (protocols, SAPs, and CSRs).
Drive the global outsourcing strategy; identify, select, and manage CROs and vendors, establishing high-level governance to drive performance and quality.
Develop and lead a global site-selection strategy that prioritizes high-performing centers and KOLs, ensuring our programs are positioned well to accelerate enrollment and data quality.
Contribute to global clinical and regulatory submissions, ensuring the operational roadmap for the IND is aligned with global standards.
Ensure adherence to regulatory requirements and guidelines governing clinical trials; maintain inspection readiness throughout the trial lifecycle.
Collaborate with internal AI/ML and Data Science teams to identify and implement technology-driven solutions to increase speed, scale, and probability of success across the clinical development lifecycle.
Requires some travel.