Title: Medical Director, Immunology Programs
Type: Onsite
About Sail:
Sail Biomedicines is harnessing evolutionary and artificial intelligence to revolutionize programmable medicines. Sail’s platform combines first-in-class programmable RNA technology (Endless RNATM or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.
The Role:
We are seeking an experienced Medical Director to lead our Immunology Programs towards clinical testing. The successful candidate will provide medical expertise and strategic direction for our immunology pipeline, from drug candidate nomination through IND and clinical development. This key leadership role will collaborate across multiple functions, including research, biomarker, regulatory, TDO, and business development to advance our existing and growing immunology pipeline of RNA-based in vivo reprogramming drug candidates towards clinical testing. This is an onsite position, with in office expectations tailored to the specific needs of the team, ensuring that responsibilities align with the team's requirements.
Responsibilities:
Provide medical and scientific leadership for immunology clinical development programs
Develop and implement clinical development strategies and study protocols
Collaborate with research teams to facilitate translation of preclinical concepts into clinical applications, definition of TPP/MPP, CDP, indication selection and assessment competitive therapeutic landscape
Author clinical sections of regulatory documents (INDs, CTAs, BLAs, etc.); serve as medical monitor for clinical trials, ensuring patient safety and data integrity; analyze and interpret clinical data to guide program decision-making
Represent the company at scientific meetings and engage with key opinion leaders
Contribute to publications and presentations of clinical research findings
Partner with business development on strategic opportunities/partnership discussions and external collaborations
Qualifications:
MD or MD/PhD with board certification in immunology, rheumatology, allergy, or relevant specialty
Minimum 5-7 years of industry experience in clinical development within immunology or related therapeutic areas, with strong knowledge of immune-mediated diseases across autoimmune and immuno-oncology and current treatment landscapes
Demonstrated track record of successful contribution to immunotherapy development programs; experience with clinical development of CAR cell therapy products and/or RNA-LNP products strongly preferred, but not required.
Strong understanding of regulatory requirements for drug development
Experience in Medical Monitoring
Excellent knowledge of translational immunology and biomarker development
Experience with regulatory submissions and interactions with health authorities
Experience as a medical monitor for clinical trials and familiarity with GXP guidelines
Strong scientific publication record and presentation skills
Outstanding communication skills and ability to translate complex scientific concepts
Proven ability to work effectively in cross-functional teams
Preferred Qualifications:
Experience with both early and late-stage clinical development programs
Background in designing innovative clinical trials
Experience with various immunotherapeutic modalities and especially RNA, antibodies and/or cell therapies is preferred.
Understanding of precision medicine approaches in immunology
Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.