What if you could join a company rapidly advancing its first candidate molecule to clinic and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way?
What if you could be the first hire in Clinical Operations with the opportunity to create strategy and build your team as we expand our clinical pipeline?
What this position is all about: As a Head of Clinical Operations (Senior Director or VP; level commensurate with experience), you will play a pivotal role in defining the overall operational strategy and drive the advancement of our portfolio of clinical programs. You will report to the SVP, Translational Medicine and work closely with cross-functional teams, external CROs, and thought leaders to ensure the successful execution of clinical trials. You will have the unique opportunity to operate in a highly visible capacity to develop the clinical operations function. Your contributions will be instrumental in shaping the success of our clinical trials and advancing our mission.
What you would be responsible for:
Lead clinical operational strategy for assets across multiple therapeutic areas in compliance with global regulations and requirements.
All operational aspects of Cellarity's clinical trials from study concept through CSR, and regulatory submissions, in support of license applications.
Drive the design and execution of clinical development plans, including protocol development, site selection, and investigator meetings.
Oversee the selection, contract negotiation, and management of relationships with clinical research organizations (CROs) and other third-party vendors.
Identify innovative opportunities in study start up and implement best practices.
Work closely with key stakeholders to coordinate study objectives/protocols, timelines, and resource requirements.
Partner with regulatory peers to support timely and quality regulatory submissions.
Develop and manage the clinical operations budget, ensuring optimal allocation of resources to meet project timelines and milestones.
Collaborate with KOLs on feedback on development plans and clinical study protocols.
Identify potential risks and develop mitigation plans to proactively address any issues that may impact quality and/or trial timelines.
Represent Cellarity at conferences, investigator meetings, regulatory engagements.
Present regularly to Cellarity executive team and Board of Directors.
What experiences will you need:
Advanced degree in life sciences or related field.
Minimum of 10 years of relevant industry experience in clinical operations with specific experience supporting early-stage programs.
Solid understanding of US and global regulations and guidelines with additional global experience preferred.
Experience and skillset selecting and managing CROs, vendors and/or clinical trial consultants
Experience with alliance management
Ability to interpret and integrate scientific and clinical data
Demonstrated prior success in delivering clinical trial milestones on time and on budget
In-depth knowledge of global clinical trial regulations and guidelines.
Strong strategic thinking, decision-making, and problem-solving skills.
Excellent written and oral communication and people skills with the ability to build and maintain effective relationships.
Remote/hybrid role possible; Local highly preferred. Ability to be on site in Somerville, MA for critical meetings and for developing relationships is important.