Medical Director

Full-time · Cambridge, United States

Job description

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


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