Medical Director / Senior Medical Director, Rheumatology

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $290M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

Synthekine is seeking a Medical Director/Senior Medical Director of Clinical Sciences to join an exciting and dynamic start-up environment to manage the clinical development research studies for our autoimmune cell therapy programs including phase I-IV studies. The Medical Director/Senior Medical Director, Rheumatology will have oversight, execution, and management of clinical trials for our innovative pipeline of early-stage T cell therapies. This individual will have a strong understanding of drug product development including clinical trial management, IND, and NDA submissions, medical monitoring, and GCP principles. This role can be located in the Menlo Park, CA office or remote.

Key Responsibilities:

• Participate in and/or lead cross-functional project teams to design and implement clinical studies.
• Provide expert opinion and writing support for trial-related documents including protocols, investigator brochures, charters, clinical study reports and review of clinical trial documents.
• Define clinical study protocols; recommend new clinical trial sites and investigators; recommend specific data outputs and publications.
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
• Collaborate with Clinical Operations to expedite execution of clinical trials.
• Help devise and execute 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.
• Represent Synthekine in external scientific and medical forums.
• Work with internal teams to apply regulatory guidelines relevant to the biotech industry and ensure compliance with these external guidelines.
• Work with internal discovery scientists, translational scientists, technical operations/manufacturing teams, regulatory affairs, safety and pharmacovigilance, external consultants or CROs in a cross functional manner.
  
  
  

Requirements:

• MD or MD-PhD with relevant medical experience and will ideally have subspecialty training and board certification in immunology, rheumatology, or a related field.
• Director: Minimum of 3 years industry or comparable experience in the management, execution, and reporting of clinical trials.
• Sr. Director: Minimum of 5 years industry or comparable experience in management, execution, and reporting of clinical trials.
• Strong knowledge of the drug development process, with experience in early phase trials preferred.
• Experience in the development of immuno-therapeutics in Rheumatology, preferred.
• Demonstrated ability to independently evaluate, interpret, and present complex scientific data.
• Good understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, and clinical pharmacology).
• Demonstrated ability to work cross functionally with a multi-disciplinary team of peers and outside experts.
• Experience participating in FDA document preparation, ideally with FDA interaction preferred.
• Ability to work in a fast-paced, start-up environment.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Demonstrated scientific productivity (publication, abstracts, etc.).
  
  
  

The anticipated salary range for the position of Medical Director, Rheumatology is $284,000-345,000. The anticipated salary range for the position of Sr. Medical Director, Rheumatology based is $313,000-380,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state, federal and local laws regarding pay practices.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.