Medical Director, Clinical Development
$270,000—$310,000
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Posted 34 days ago
SENIORITY
Manager
SALARY
$270,000—$310,000
About the role
- Include: Clinical Development Strategy and Study Design
- Contribute to the planning, design, development, and implementation of clinical trials for assigned drug candidates
- Apply knowledge of disease mechanisms to support selection and interpretation of biomarkers, pharmacodynamic and clinical endpoints, and patient stratification considerations
- Contribute to the development and implementation of effective, timely studies to establish the safety, tolerability, pharmacodynamic activity, and efficacy of assigned drug candidates
- Contribute to integrated product and clinical development plans, ensuring medical monitoring activities align with broader program objectives
- Provide medical input to Research, Translational Medicine, Biomarkers, and other cross-functional partners on decisions with clinical components and implications
- Medical Monitoring, Safety, and Participant Oversight
- Serve as medical monitor for assigned studies, providing timely medical guidance to study teams, investigators, CROs, vendors, and advisors
- Review clinical and safety data, eligibility questions, protocol deviations, adverse events, serious adverse events, and other medically relevant information to support participant safety and study integrity
- Partner with Pharmacovigilance and Clinical Development leadership to support safety surveillance, signal detection, benefit-risk assessment, and timely escalation of emerging safety concerns
- Support study-level risk assessments, medical monitoring plans, data review plans, dose review discussions, and safety review meetings
- Clinical Study Execution and Vendor Oversight
- Collaborate with Clinical Operations to ensure assigned study activities are completed in accordance with applicable regulations, GCP, ICH guidelines, Dyne SOPs, and study timelines
- Ensure compliance with applicable regulatory standards related to global clinical trials and interactions with physicians
- Support the development, implementation, and maintenance of SOPs for clinical trials and related activities, as required
- Support site engagement, investigator training, enrollment strategy, medical issue resolution, and inspection readiness for assigned studies
- Partner with Clinical Operations on outsourcing and in-house approaches for clinical development capabilities and implementation plans
- Manage relationships with CROs, vendors, and external collaborative partners supporting clinical development efforts
- Data Review, Regulatory Support, and Scientific Deliverables
- Review and interpret emerging clinical, safety, biomarker, pharmacodynamic, and endpoint data to inform study conduct, program strategy, and regulatory interactions
- Contribute medical review and interpretation for protocols, investigator brochures, informed consent forms, clinical study reports, briefing materials, safety narratives, and regulatory responses
- Support regulatory submissions and interactions with health authorities by providing study-specific medical input and data interpretation
- Represent the company in interactions with regulatory agencies, as required
- Manage the writing, review, and accountability for key clinical and regulatory documents, including protocols, investigator brochures, informed consent forms, regulatory submissions, abstracts, peer-reviewed articles, presentations, and publications
- Support abstracts, presentations, publications, and other scientific communications, as appropriate
- External Engagement and Relationship Management
- Identify, manage, and interface with external collaborators, investigators, advisors, and key opinion leaders to support clinical development strategies for a novel class of therapeutics
- Develop and maintain professional relationships with academic and community-based study sites
- Participate, as requested, in Business Development due diligence, advisory boards, investigator meetings, and presentations to external constituencies
- Cross-Functional Leadership and Communication
- Maintain accountability for relevant timelines and deliverables in close partnership with functional counterparts and clinical development colleagues
- Coordinate and communicate with internal departments and external vendors to ensure study objectives, timelines, and deliverables are accomplished
- Manage, coordinate, and provide ongoing assessment, evaluation, and communication with internal departments and external vendors to support successful study execution
- Provide timely updates to Clinical Development leadership and cross-functional partners on study progress, medical issues, emerging risks, changes in scope, schedule, and resources
- Interface with functions within and outside of R&D, including Finance, Regulatory Affairs, Legal, Commercial, and Medical Affairs
- Provide leadership and mentorship to clinical development team members, including matrixed team members and potential direct reports
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
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Two examples you can talk through
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A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
