Sr. Manager/Associate Director, Medical Affairs
New
B
BridgeBioBiotechnology, rare disease
Location: Remote - USA; a U.S.-based remote roleFull-TimeDirector
SalarySalary $165,000 — $210,000 USD; anticipated salary range for candidates for this role who will work in California.
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Job Details
- Experience
- Typically 3–5 years of pharmaceutical or biotechnology Medical Affairs experience. Candidates with an MS or similar degree should have 5 or more years of demonstrated pharmaceutical or biotechnology Medical Affairs experience. Candidates with a PharmD or PhD may qualify with less industry experience if supported by a Medical Affairs fellowship or equivalent.
- Required Skills
- Project Management
Requirements
- Hold a PharmD, PhD, genetic counseling degree, NP/advanced practice degree, MS, or another relevant advanced scientific or healthcare degree.
- Have typically 3–5 years of pharmaceutical or biotechnology Medical Affairs experience.
- Bring hands-on experience with medical review, MLR submissions, scientific content development, and advisory board or symposium execution.
- Candidates with an MS or similar degree should have 5 or more years of demonstrated pharmaceutical or biotechnology Medical Affairs experience.
- Candidates with a PharmD or PhD may qualify with less industry experience if supported by a Medical Affairs fellowship or equivalent.
- Demonstrate strong project-management and organizational skills and ability to manage multiple complex workstreams and deadlines independently.
- Have strong scientific writing and communication skills and exceptional attention to detail.
- Have working knowledge of clinical trial data and basic biostatistical concepts, including framing analysis questions, interpreting outputs, and summarizing findings.
- Be able to distinguish executional decisions from scientific or strategic issues that require escalation.
- Be able to travel as needed, with travel up to 50% expected.
- Experience in pediatric rare disease, genetics, skeletal dysplasia, or launch-stage Medical Affairs is preferred but not required.
Responsibilities
- Review scientific and medical materials for accuracy, interpretation of clinical data, source-document consistency, and alignment with approved scientific communications.
- Prepare, submit, and manage Medical Affairs materials through the Medical, Legal, and Regulatory review process, including documentation, comments, version control, resubmissions, and approval tracking.
- Partner with the Medical Information lead to identify content needs and review and support development of Medical Information materials.
- Manage advisory board execution, including advisor coordination, timelines, pre-read materials, logistics, agency management, review, and post-meeting deliverables.
- Work with Medical Directors to develop advisory board objectives, agendas, discussion questions, presentations, and scientific content.
- Support company-sponsored symposia by coordinating presentations, faculty review, MLR submission, revisions, and final materials.
- Support analyses of clinical trial, natural history, and real-world data by framing questions, coordinating with Biostatistics and Data Management, and summarizing results.
- Support evaluation of data-generation opportunities, including investigator-initiated studies, registries, chart reviews, and real-world evidence collaborations.
- Manage Medical Affairs agency and vendor relationships, timelines, deliverables, meetings, revisions, and execution.
- Track milestones, risks, dependencies, and budgets, resolve execution issues, and coordinate cross-functional Medical Affairs initiatives.
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