Senior Medical Director

Company Overview

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in severe liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey.  

Position Summary:

The Senior Medical Director is responsible for medical and clinical development activities for Boston Pharmaceuticals MASH portfolio from Phase 3 planning through product approval and post-approval life cycle management. This individual will be responsible for both day-to-day medical monitoring activities as well as strategic protocol development and management. The Senior Medical Director will be an active member of Boston Pharmaceuticals’ cross-functional program team and will manage relationships with CROs, clinical sites, and KOLs. Strong communication and leadership skills are required along with deep experience in drug development.

Key Responsibilities:

• In collaboration with the leadership team and KOLs, draft the protocol concept of the F3/F4 Phase 2 open-label study and subsequently initiate and oversee this study along with the Clinical Operations team
• Partner with leadership team to help develop the non-invasive tests (NITs) strategy for future clinical development
• Maintain the highest quality clinical programs, following GCP and ICH guidelines. Execute on timely reporting of safety signals to regulatory authorities and the generation of clinical study reports.
• Maintain real time knowledge of the competitive landscape in MASH and liver related diseases.
• Communicate and collaborate effectively with senior R&D leaders and functional counterparts and colleagues to ensure tight strategic integration of product development plans across the development functions.
• Support and drive global regulatory approvals for liver pipeline products.
• Present to key internal and external constituents including KOLs, principal investigators, patient advocacy groups, board members, vendors, and potential partners.
• Participate in the writing of protocols, presentations, publications and other documents (e.g informed consent forms).

Qualifications:

• MD or MD/PhD with significant drug development industry experience.  
• Sub-specialty training in Hepatology, Endocrinology, Gastroenterology preferred.
• Prior experience developing drugs for various liver diseases required. 
• Experience designing and executing global Phase 3 trials of 600 patients.
• Proven track record identifying critical gaps in drug development programs and addressing those issues with urgency.
• Prior exposure to PK studies preferred.
• Excellent communication and writing skills, a track record of publications and superb presentation skills.
• Takes personal accountability for outcomes. Thrives on increasing levels of responsibility by confidently taking actions to move the business forward.
• Experience interacting with regulatory bodies and contributing to a wide variety of submissions, including INDs, CTAs, and NDA/BLAs/MAA, both US and ex-US.
• Comfortable working with cross-functional drug development team as well as the Boston Pharma Leadership Team
• Experience working with biotech/pharma partner(s)

·        Embraces and embodies Boston Pharmaceuticals’ corporate values: Commitment to Patients, Decisive Innovation, Purposeful Urgency, Passion for Excellence, One Team