Medical Director/Sr Medical Director

GENERAL SUMMARY:
Reporting to the Chief Medical Officer, the (Senior) Medical Director is accountable for the design, execution, and analysis of clinical trials for our novel therapeutics. We expect all AltruBio team members to perform in a way consistent with AltruBio’s values – visionary, pioneering, agile, caring and excellent.

COMPANY:

AltruBio is developing first-in-class immune-modulators to target diseases of the immune system. Its world-class global team brings a breadth of expertise in immunology and drug development to develop biologic treatments for patients. AltruBio has developed and clinically validated a first-in-class immune checkpoint regulator mechanism to selectively target T-cells. Our antibodies enhance PSGL-1’s natural immune function to down regulate late-stage chronically activated T-cells. ALTB-168 is a first-generation PSGL-1 agonist with clinically validated safety, efficacy and durability demonstrated across multiple Phase 1 and Phase 2 trials. ALTB-268, our next-generation PSGL-1 agonist, has an improved target product profile including increased potency and subcutaneous dosing, allowing for expansion to new indications. Our mission is to: 1.) Further the understanding of fundamental mechanisms of immune system regulation, 2) Create better therapies for patients with immune diseases, 3.) Create innovative solutions in drug development and patient care paradigms.

RESPONSIBILITIES:

• Provides clinical leadership across investigators, CROs, internal stakeholders and consultants.
• Has lead accountability on the study teams for delivery of study protocols, study conduct, and study readouts, including compliance with local and global standards of Good Clinical Practice. 
• Provides medical expertise and helps ensure cross-functional alignment throughout all stages of development.
• Serves as medical monitor on clinical studies and develops risk management plans
• Establishes strong partnerships with KOLs and other stakeholders to gather their input.
• Serves as the primary clinical author of development plans, study protocols, amendments, ICFs, IBs, INDs, annual reports, CSRs, regulatory submissions / correspondence, and project-related documents. Accountable for the accuracy of all medical content of such documents.
• Collaborates to identify program risks, and to create and implement mitigation strategies.
• Presents study data internally and externally, including author publications of clinical data (abstracts, journal articles, etc.).
• Other duties as assigned.

QUALIFICATIONS:

Education:

• Medical Degree (M.D.)
• Training in a US-based residency training program.
• Fellowship in gastroenterology/rheumatology/dermatology a plus.

Experience:

• At least three years of clinical research experience in biotech/pharma/CRO company.
• Additional experience and/or training in IBD is highly desirable.

Job Specific Skills:

• Experience writing clinical research protocols (preferably beyond Ph II) and acting as a medical monitor.
• Experience in data analysis, data interpretation, and medical writing
• Effective written and verbal communication skills, including public speaking.
• Knowledge of ICH-GCP and FDA/international regulatory guidelines.

Biotech Start-up Skills:

• Strong leadership ability including traits of flexibility and innovation
• Demonstrated ability to act effectively as a medical expert in a matrix environment.
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• Ability to multi-task, overseeing different activities and different projects at the same time.
• Personal accountability for delivery of quality output according to timelines
• Flexibility, and ability to drive change and simplify processes.
• Teamwork and cross-functional partnership.
• Other:
• Ability to travel (approximately 3 days/month).
• AltruBio is headquartered in San Francisco. Remote/hybrid is acceptable but will require additional travel to San Francisco for key meetings.

COMPENSATION:

• Compensation range $250,000k/yr - $330,000k/yr with 20-25% target bonus – compensation dependent on qualifications and geography

We will not engage with external recruiters for this position.
This position is not eligible for Visa sponsorship.