Medical Director - Cambridge, United States - LanceSoft

Description

Seeking an experienced Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease.

In this position, you will be an integral part of the clinical development team, supporting the execution of late-stage clinical studies.

The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast-paced environment.

Provide medical expertise and leadership in designing and implementing clinical development strategies aligned with company objectives.

Job ResponsibilitiesClinical Trial Strategy and Design:
Collaborate with cross-functional teams (including Clinical Operations, Biostatistics Regulatory Affairs, Patient Safety, and Pharmacology/Pharmacometrics) to design and implement clinical trialsEnsure that clinical trial protocols align with scientific and regulatory requirementsOversee patient recruitment, data collection, and safety monitoring during trials

Medical Oversight:
Provide medical expertise to study teams, investigators, and site staffReview and interpret clinical trial data, including safety and efficacy endpointsMake informed decisions based on medical insights to optimize trial outcomes

Regulatory Interactions:
Engage with regulatory agencies (such as the FDA or EMA) during clinical developmentPrepare and submit clinical trial applications, investigator brochures, and other regulatory documentsAddress regulatory queries and ensure compliance with guidelines

Clinical Development Strategy:
Contribute to the overall clinical development strategy for the company's pipeline productsIdentify opportunities for expansion into new indications or patient populationsEvaluate scientific literature and competitive landscape to inform strategic decisionsKOL Engagement and

Scientific Communication:
Build relationships with Key Opinion Leaders (KOLs) in relevant therapeutic areasPresent clinical trial results at scientific conferences and meetingsCollaborate with external experts to enhance product understandingTeam Leadership and Mentorship:Depending on the candidate's expertise level, the responsibilities may include leading a team of clinical professionals, including Clinical Scientists and Medical MonitorsEffectively fosters productive and collegial working relationships with internal and external stakeholders in a cross-functional, matrix environmentAdditional InfoThis is a hybrid/remote role for the candidate; however, if the candidate is local to the area, the candidate will be expected to come into the office occasionallyAdvanced scientific degree (MD or DO, PhD, PharmD)Must have experience leading all aspects of clinical trialsMust have pharma clinical trial /R&D experience (3-5 years)Rare disease experience and or gastroenterology/hepatology experience in clinical development preferredSolution- and results-oriented, with a sense of urgencyMust have experience and be willing to perform in-depth clinical data review