5 часов назад
Associate Medical Director, Clinical Development, Rare Neurology (SMA)
194 000 - 266 750$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Medical Director, Clinical Development, Rare Neurology (SMA) (Clinical Development/SMA): Leading clinical and scientific oversight for spinal muscular atrophy studies from start-up through close-out with an accent on medical monitoring, safety and efficacy interpretation, and regulatory documentation. Focus on coordinating cross-functional study execution, protecting participant safety, maintaining data integrity, and supporting global multicenter clinical development.
Location: Cambridge, Massachusetts, United States; occasional domestic and international travel may be required.
Base salary: $194,000–$266,750 per year, plus eligible short- and long-term incentives.
Company
is a mid-sized biotechnology company developing life-changing medicines, including therapies for rare neurological diseases.
What you will do
- Serve as Study Medical Director for assigned spinal muscular atrophy studies from start-up through conduct, analysis, reporting, and close-out.
- Develop and review study protocols, amendments, clinical study reports, training materials, regulatory responses, and other clinical documents.
- Perform medical monitoring and interpret safety, efficacy, and clinical data to support participant safety and evidence-based decisions.
- Partner with Clinical Operations, Regulatory, Biostatistics, Data Management, Medical Writing, Pharmacovigilance, investigators, vendors, and external experts.
- Identify and escalate clinical, safety, data-quality, and operational risks while supporting enrollment and protocol adherence.
- Contribute to regulatory submissions, health authority interactions, investigator meetings, advisory boards, congress presentations, and publications.
Requirements
- MD, PharmD, and/or PhD with approximately five years of relevant clinical research experience.
- Hands-on experience with protocol development, medical monitoring, clinical data review, safety and efficacy interpretation, and clinical or regulatory documentation.
- Working knowledge of GCP, clinical trial design and execution, statistical principles for clinical trial interpretation, and clinical research regulations.
- Strong organizational, project management, written communication, and verbal communication skills.
- Experience building relationships with cross-functional and external stakeholders in a global matrix environment.
- Ability to travel occasionally for scientific meetings, investigator meetings, and clinical site engagement.
Nice to have
- Experience in neurology and/or rare diseases.
- Experience supporting global, multicenter interventional clinical studies.
- Experience with regulatory submissions, clinical study reports, publications, investigator meetings, or advisory boards.
Culture & Benefits
- Full-time employment in a global, collaborative, and inclusive biotechnology environment.
- Medical, dental, vision, life, disability, and wellness benefits.
- Paid vacation, company holidays, personal-significance days, sick time, and parental leave.
- 401(k) plan with company matching, employee stock purchase plan, and incentive opportunities.
- Tuition reimbursement of up to $10,000 per calendar year and employee resource group participation.
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