Medical Director

Company Overview 

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH).  

Position Summary: 

The Medical Director will be responsible for medical and clinical development activities for Boston Pharmaceuticals MASH portfolio through Phase 3, to product approval and post-approval life cycle management.  

Key Responsibilities: 

• Oversee the successful conduct of the Phase 2a Part B OLE study 

• 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. 

• Communicate regularly and effectively with senior leaders across the R&D organization. 

• Maintain real time knowledge of the competitive landscape in MASH and liver related diseases.  

• 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 pharma/biotech partners. 

• Accountable for relevant timelines and deliverables. 

• Collaborate closely with functional counterparts and colleagues to ensure tight strategic integration of product development plans across the development functions.  

• Participate in the writing of protocols, presentations, and publications (regulatory submissions, original articles, abstracts, etc.) 

• Prepare documents including protocols, IBs, and 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. 

• Regulatory experience with INDs, CTAs, End-of-Phase 2 meetings and NDA/BLAs/MAA, both US and ex-US. 

• Comfortable working with cross-functional drug development team as well as 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