Senior Medical Director

CultureHQ

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

Posted 7/16/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $320,000 - $375,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development, particularly in oncology, with a strong focus on trial design, execution, and regulatory submissions. Proven ability to lead cross-functional teams and communicate effectively with diverse stakeholders in a fast-paced environment.

Highest-signal resume keywords

MD With Experience In Medical OncologyClinical Development Experience In Biotechnology Or Pharmaceutical CompanyDesign And Execution Of Clinical TrialsRegulatory Submissions ExperienceStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DesignClinical Trial MonitoringRegulatory SubmissionsBiostatisticsData ManagementClinical OperationsTranslational SciencesClinical PharmacologyGood Clinical Practice (GCP)Good Medical Practice

Soft Skills

Critical Strategic ThinkingCreative Problem SolvingCollaborationInterpersonal SkillsOrganization And Planning

Industry Keywords

GISTClinical Development ProgramLife Cycle ManagementMedical Monitor ResponsibilitiesClinical Trial SitesContract Research Organizations (CROs)Investigators’ BrochureEthics CommitteesInstitutional Review Boards (IRBs)Target Product Profile

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
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
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)
Develop a deep understanding of the clinical and competitive environment and work with the asset team to develop the target product profile

Requirements

What you’ll need

MD with experience in medical oncology highly preferred
Minimum of 4 years of experience in clinical development at a biotechnology or pharmaceutical company
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 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

Benefits

Comp & perks

100% coverage of medical, dental, and vision premiums for employees and family
Funding up to 75% of in-network deductibles
401(k) match with immediate vesting
Generous paid time off
12 weeks of fully paid parental leave
Paid family and medical leave for all employees
Company-paid short-term disability coverage for up to 20 weeks
Wellness programs
Tuition reimbursement
Inclusive family-forming support