2 дня назад
Associate Medical Director, Clinical Development Rare Movement Disorders (Rare Neurology)
194 000 - 267 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Medical Director, Clinical Development Rare Movement Disorders (Rare Neurology): Supporting the development and oversight of early- and late-stage clinical programs for rare movement disorders, including protocol design, trial execution, safety and efficacy interpretation, and regulatory interactions with an accent on clinical development in Friedreich ataxia and other rare neurology indications. Focus on designing and interpreting clinical trials, evaluating biomarkers and emerging therapeutic platforms, and coordinating cross-functional study teams and regulatory submissions.
Location: Cambridge, MA, United States
Base compensation: $194,000–$267,000 per year
Company
is a mid-sized biotechnology company developing life-changing medicines in rare neurology and other therapeutic areas.
What you will do
- Support early- and late-stage clinical development programs for rare movement disorders, including Friedreich ataxia.
- Develop and oversee study protocols, amendments, clinical study reports, training materials, and other clinical and regulatory documents.
- Monitor, review, and interpret safety and efficacy data from assigned clinical trials.
- Represent Clinical Development on cross-functional study management teams and support study quality and execution.
- Contribute to regulatory submissions, regulatory interactions, publications, presentations, investigator meetings, and advisory boards.
- Stay current with regulations and guidelines relevant to the therapeutic area.
Requirements
- MD, Ph.D., and/or PharmD with at least 5 years of clinical research experience in academia and/or industry.
- Experience analyzing and interpreting clinical trials.
- Knowledge of GCP, clinical trial design and execution, biostatistics, and regulatory requirements.
- Strong organizational and project management skills in a fast-paced, highly matrixed environment.
- Experience building relationships with Clinical Operations, Regulatory, Biostatistics, clinical investigators, and other stakeholders.
Nice to have
- Experience in neurology and/or rare diseases.
- Experience with biomarkers, wearables, and digital health technologies.
- Experience evaluating novel therapeutic mechanisms or emerging scientific platforms.
- Strong written and verbal communication skills.
- Willingness to travel occasionally to scientific meetings and clinical sites, domestically and internationally.
Culture & Benefits
- Full-time employment with short-term and long-term incentive opportunities, including cash bonuses and equity incentives.
- Medical, dental, vision, life, disability, fitness, and wellness benefits.
- At least 15 vacation days, end-of-year shutdown time, company holidays, personal-significance days, and 80 hours of sick time annually.
- Paid maternity and parental leave.
- 401(k) with company matching, employee stock purchase plan, and tuition reimbursement of up to $10,000 per year.
- Employee Resource Groups and an inclusive workplace focused on collaboration, learning, and professional growth.
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