Senior Medical Director

• In collaboration with the Head of Clinical Development, provide strategic and medical leadership for the bezuclastinib clinical development program in GIST 

• Provide clinical and medical support to life cycle management activities in GIST as needed 

• Collaborate with commercial and medical affairs colleagues to support launch activities for bezuclastinib in GIST 

• Provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation for the Peak clinical trial. 

• Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, good clinical practice (GCP) and good medical practice. 

• Work collaboratively with matrix team members in trial execution and oversight. Provide support to the clinical trial study team to manage safety, site education, protocol-related and eligibility questions. 

• Provide medical oversight and input into clinical trial documents including but not limited to the study protocol, informed consent form (ICF), statistical analysis plan (SAP), case report form (CRF), clinical study report (CSR) 

• Provide medical and scientific input into other documents including but not limited to the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports, etc.; 

• Collaborate with the regulatory team to develop briefing documents and other regulatory documents in support of submissions 

• Interact with clinical trial sites, external clinical experts, contract research organizations (CROs) and regulatory agencies, as needed.  

• Support investigator meetings, steering committee meetings, data monitoring committee reviews as the study physician. 

• Assist with regulatory submissions by answering protocol-related questions from regulatory authorities, ethics committees and institutional review boards (IRBs) 

• You will work collaboratively with all stakeholders from internal cross functional team members to external consultants, CRO partners, key opinion leaders, investigators, and various committee members.   

• You will develop a deep understanding of the clinical and competitive environment and work with the asset team to develop the target product profile 

Qualifications:

• MD with experience in medical oncology highly preferred 

• Minimum of 4 years of experience in clinical development at a biotechnology or pharmaceutical company.  Experience in late phase is highly preferred  

• Critical strategic thinking to guide the clinical development program and life cycle management activities  

• Significant knowledge and experience in the design and execution of clinical trials with experience in overseeing global clinical trials from design through execution. Experience with regulatory submissions is highly preferred. 

• Demonstrated experience in clinical research, including designing, planning and monitoring clinical trials, particularly Phases 2-3 

• A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, result oriented environment. 

• Outstanding communication skills (written and verbal, both formal and informal). 

• Strong interpersonal, organization, and planning and communication skills.  Effective skills directed toward driving collaboration, achieving results, influencing, and reaching consensus across internal and external stakeholders 
• A working knowledge of biostatistics, data management, clinical operations, translational sciences, clinical pharmacology and other technical disciplines and processes intimate with the drug development process 

Salary Range:

$320,000 - 375,00 USD