What are the responsibilities and job description for the Director Clinical Operations position at GEMMA Biotherapeutics?
GEMMABio is a therapeutics company focused on speeding the research of and global access to life-changing advanced therapies for those living with rare diseases. The company will provide research and product development functions to bring gene therapy discoveries from the bench to the bedside faster and affordably.
GEMMABio is led by gene therapy industry pioneer Jim Wilson and his team of experts, who previously conducted their work in academia. Wilson is also the Chairperson of Franklin Biolabs, a Contract Research Organization. The collective goal of the two affiliated companies is to translate innovative scientific work into clinical trials, to then commercialize and distribute the new therapies around the world to patients who need them most.
Job Summary
GEMMABio’s genetic therapy programs involve multiple clinical indications including neuromuscular, cardiovascular, oncology, metabolic, and infectious disease. We are currently seeking a Clinical Operations Director to be responsible for the scientific and clinical strategy for several gene therapy programs under the leadership of the Chief Medical Officer.
This position will work in close collaboration with multiple functional groups at Gemma, especially the Translational, CMC, and Regulatory teams. The candidate will be responsible for clinical operation plans and clinical vendors oversight (including but not limited to CRO, and labs), clinical protocol execution, and oversight of clinical sites on one or more programs.
In addition, the Director, Clinical Operations is responsible for technical input on clinical studies. This candidate will serve as a key functional leader and subject matter expert in clinical operation and will work collaboratively with other functional leads in the achievement of departmental and corporate objectives and initiatives. The candidate will proactively seek to improve the efficiency, effectiveness, and quality of clinical programs at Gemma Biotherapeutics including budget, timelines, and deliverables.
The Director of clinical operations will work closely with external key opinion leader network and patient advocacy groups to bring operational scientific, patient, an insight to one or more clinical programs. The director will also contribute and participate in external clinical investigator or advisory meetings as deemed appropriate.
The candidate is expected to promote a strong quality culture within clinical operations ensuring clinical trials are designed, managed, and executed according to GCP/ ICH requirements, corporate/ department SOPs/ company policies, and industry best practices.
Requirements
- A bachelor’s degree or higher with a minimum of 7 to 10 years of clinical operation experience in the pharmaceutical/biotech industry or equivalent environment.
- Strong experience in the set-up and management of domestic and international early and late phase clinical trials either directly or via CRO/vendor management.
- Experience managing multiple projects and priorities.
- Strong working knowledge of GCP/ICH guidelines.
- Experience developing and managing departmental and study budgets and timelines.
- Strong interpersonal skills with demonstrated ability to effectively work with internal and external cross-functional groups.
- Extensive knowledge of drug development functions relevant to clinical trial conduct (e.g., data management, biostatistics, pharmacovigilance, CMC/supply chain management, etc.).
- Demonstrated ability to collaborate effectively in cross-functional teams, to lead and develop a high-performing team and to mentor team members at all levels.
- Excellent written, communication and interpersonal skills, and demonstrated cultural agility.
- A minimum of 5 years of clinical operation management role in biotech.
- Experience in cell and gene therapy clinical operation is preferred but not required.
Application Note
GEMMABio is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at GEMMABio via email, the Internet, or directly without a valid written search agreement for this role will be deemed the sole property of GEMMABio and no fee will be paid in the event the candidate is hired.