Associate Director, Clinical Operations

Generate Biomedicines

3d•$162,000 - $227,000

About The Position

As an Associate Director 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.

Requirements

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

Nice To Haves

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

Responsibilities

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