Associate Director, Clinical Operations

The Role:

As an AssociateDirector of Clinical Operations, the qualified candidate will be excited about and capable of planning and executing early stage clinical trials. The candidate will interface with internal and external stakeholders to plan, execute and problem solve before and during the life of clinical trials with an initial focus on Oncology programs.. The candidate will focus on site- and Contract Research Organization (CRO)-facing interactions to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical (including safety and efficacy) and translational data to support evaluation of the drugs under study. The candidate will be clear and efficient in communicating with cross-functional team members to achieve these goals. The candidate will serve as the clinical operations program lead for at least one program and any studies associated, in addition to leading a team of operations staff.

Here's how you will contribute:

Develop clinical operations strategy for respective program in development, either directly or by leading study staff depending on the stage of the agent

Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical study reports, presentations, regulatory submissions and publications

Evaluate external collaborators including Contract Research Organizations (CROs) and sites and select the best candidates for each needed function. Develop vendor scope of -work, contract, quality, monitoring and budget.

Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators. Ensure GCP compliance.

Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered

Develop and manage study timelines, working with internal partners (including but not limited to clinical development, clinical pharmacology and other quantitative functions, data management, biomarkers and translational, CMC, regulatory affairs and project management)

Attend and, where appropriate, present at study site initiation meetings and study calls

Patient recruitment planning and forecasting

Manage or Mentor Clinical Operations team members on the program

The Ideal Candidate will have:

Minimum 8 years of experience in clinical operations across at least 2 therapeutics areas, including oncology

Experience managing CROs and vendors both in the US and in international clinical trials

Experience in site initiation visits, site management, data cuts for publication and regulatory requirements

Understanding of the drug development process from IND to NDA

Dedication to collaborative work in a fast-paced environment; open-mindedness to shifting strategy in a data-guided manner

Ability to communicate effectively and efficiently and willingness to train other team-members within and outside of Clinical Operations

Experience in large Pharma and biotech and with biomarker-selected studies preferred but not required Experience with at least one report is preferred, but a strong candidate with hands-on experience and a growth mindset will be considered

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this ap …