Medical Director

Overview

Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizingpowerand rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers that provide precise targeting and controlled cytotoxicity. These innovative therapies aim to reset and regenerate the immune system, driving transformative outcomes in healthcare. The company is at the forefront of developing next-generation treatments that address critical medical needs.

About The Role:

The Medical Director will oversee the direction, planning, execution and interpretation of clinical trials and data collection activities for early phase clinical studies in the development portfolio. The individual in this role will establish and approve scientific methods for design and implementation of clinical protocols, medical monitoring, data collecting and final reports. Together with the Clinical Trial Manager, may recruit clinical investigators, negotiate study design and manage CROs.

Responsibilities also include regulatory interactions with the FDA and other health authorities. Monitors adherence to protocols and determines study completion.

What You’ll Do:

• Provide medical monitoring to multiple clinical trials.
• Lead project teams to design and implement clinical studies.
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents.
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
• Translate findings from research and nonclinical studies into clinical development opportunities.
• Interact with clinical investigators and thought leaders.
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines.
• Collaborate with multiple internal functions, including drug discovery & pre-clinical scientists, translational scientists, regulatory affairs, business
• Perform other duties as required.

What You’ll Bring:

• M.D with board certification or eligibility, specialized in Rheumatology, Nephrology (etc) is preferred.
• At least 3-5 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
• Proven clinical development strategist with experience designing, implementing and conducting clinical trials.
• Knowledge of conducting clinical trials, including knowledge of current treatment landscapes; experience with clinical trials in systemic lupus erythematosus useful
• Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the goals of our client.
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.
• Demonstrated ability to work well in teams in a cross functional manner.
• Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• This position anticipates up to 25% travel.

Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage inequitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization.

We take care of our employees with a competitive benefits package that medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans.