ABOUT GALLANT

Gallant Therapeutics’ are leaders in veterinary regenerative medicine on a mission to bring transformational “off-the-shelf” stem cell therapies to pets everywhere that treat the root cause of disease. With five high value clinical stage programs in development and a platform that is generating additional therapies, the company is positioned for their first FDA conditional approval in 2025, bringing a new class of therapies to animal health.

Gallant is a privately-held company and backed by top venture capital firms BOLD Capital, Digitalis Ventures, and Hill Creek Partners, and recently completed our Series A financing. We have onsite GMP manufacturing, R&D and offices headquartered in La Jolla, CA.

We offer a competitive base salary, generous health benefits, stock compensation, PTO, pet friendly offices, and virtual work environment as needed. We are a tight, incredibly smart and passionate team, deeply committed to our vision to bring “off-the-shelf” stem cell therapies to pets worldwide.

POSITION SUMMARY: The Director of Clinical Development is responsible for working under the direction of the Senior Vice President of Regulatory and Clinical Development to oversee and manage Gallant’s pipeline of clinical trials for proof of concept, pilot, and pivotal studies including reasonable expectation of effectiveness, substantial evidence of effectiveness, and target animal safety. This includes working with partner veterinary hospitals and contract research organizations (CRO) to engage, train, and execute studies in dogs and cats.

RESPONSIBILITIES

• Work as part of Gallant’s veterinary team and maintain relationships with existing, new and potential partners within the veterinary community.
• Manage all communications necessary for efficient trial completion including monitors, consultants, KOLs, CROS, clinical investigators, etc.
• Act as a liaison between the veterinary clinic, veterinarians and Gallant as needed to support the study monitors and CROs
• Oversee training materials to support training of investigators on clinical studies
• Manage generation, collection, and reporting of all study data with the clinical team
• Understand and be able to discuss white papers/articles as well as relay clinical knowledge to the investigators
• Manage the internal and contracted clinical team and manage delegation of tasks to team members including monitoring activities (oversight)
• Work directly with quality to implement clinical quality program including SOPs and work instructions to facilitate cGCP clinical studies
• Assist regulatory in preparation and review of all submissions containing clinical data
• Management of study protocols, study reports, and technical section preparation including decisions related to study contact including number of sites, number of patients, study groups, endpoints, and analysis
• Responsible for leading review, presentation and interpretation of clinical study results
• Oversight of consultants supporting clinical including statisticians, advisors, quality personnel, and clinical monitors
• Assist in pipeline planning and strategy
• Responsible to execute and drive results for key milestones
• Responsible for maintaining timelines and budgets for clinical development
• Assists with creation of technical material, white papers, and marketing pieces to support execution of clinical studies and product launches
• Assists in creation of slide decks to support internal and external communication related to Gallant clinical studies

QUALIFICATIONS

• At least 5 years in a clinical development role exhibiting ability to manage multiple complex studies at once
• Veterinary practice experience at least 3 years with small animal a plus
• Regenerative medicine/stem cell therapy experience a plus
• DVM or equivalent degree required
• Board certification a plus

MOST IMPORTANT QUALITIES

• Veterinary technical experience
• Strong communication skills, both written and speaking
• Positive attitude and growth mindset
• High integrity, authentic personality
• Remarkable discipline and organization
• Great attention to detail
• High speed of execution
• Resourcefulness, ability to get things done on your own, despite obstacles
• Strong work ethic
• Easily adapts to change, enjoys a dynamic environment
• Willingness to learn
• Ability to receive and incorporate feedback
• Loves pets!

WORK ENVIRONMENT

• San Diego or Home office
• Travel to the home base in San Diego as needed for meetings, training, etc. – 10%
• Travel to some conferences and study sites – 10%

Job Type: Full-time