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 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 of the 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.
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