Executive Medical Director, Neurology Clinical Development 3635450
| Verified Pay check_circle | Provided by the employer300USD - 350USD per year |
|---|---|
| Hours | Full-time |
| Location | Bridgewater, New Jersey |
About this job
Job Description
Be Part Of A High-Performing Team:
Join a science-led biopharmaceutical organization advancing innovative therapies for serious neurological and rare diseases. The clinical development team operates in a highly collaborative, globally connected environment and works across clinical operations, regulatory affairs, pharmacovigilance, biostatistics, toxicology, medical writing, research, and commercial strategy.
This senior medical leader will help guide a neurology-heavy portfolio that includes clinical-stage and pre-IND programs. The role offers the opportunity to provide medical and scientific leadership across multiple indications while contributing to the advancement of potentially transformative therapies for patients with conditions such as Duchenne muscular dystrophy and amyotrophic lateral sclerosis.
What's In Store For You:
- Remote opportunity available anywhere within the United States.
- Work with an East Coast-based organization while collaborating across multiple U.S. time zones.
- Lead or support one or more neurology clinical development programs.
- Contribute to both active clinical-stage programs and earlier pre-IND assets.
- Work in a highly visible role with access to senior leadership and cross-functional development teams.
- Potential opportunity for long-term contract renewal or conversion based on business needs and mutual fit.
- Travel less than 15% for occasional headquarters meetings, clinical sites, conferences, or program-related activities.
- Full-time, 40-hour-per-week schedule.
How You Will Make An Impact:
- Lead the clinical development strategy for assigned neurology programs, potentially including DMD, ALS, and other neurological indications.
- Guide programs from early clinical development through later-stage execution and regulatory milestones.
- Serve as a senior medical monitor and provide oversight of patient safety, clinical data, coding, data cleaning, and protocol-related medical decisions.
- Design and review clinical protocols, development plans, and medical strategies for clinical-stage and pre-IND assets.
- Partner closely with clinical operations on site selection, enrollment, feasibility, investigator engagement, and study execution.
- Serve as a medical escalation point for issues affecting patient safety, data quality, study integrity, or program delivery.
- Interpret clinical and safety data and communicate findings to internal leaders, investigators, regulators, and external experts.
- Author or oversee clinical content for INDs, briefing books, regulatory responses, investigator brochures, clinical study reports, and other development documents.
- Collaborate with medical writing, pharmacovigilance, safety, regulatory affairs, biostatistics, and clinical operations on regulatory and study documentation.
- Represent the organization in interactions with investigators, CROs, advisory boards, data monitoring committees, clinical sites, and regulatory authorities.
- Support scientific advisory boards, data monitoring committees, external expert discussions, and program-level decision-making.
- Maintain current knowledge of neurology drug development, gene therapy, DMD, ALS, competitor programs, and emerging scientific data.
- Manage clinical development budgets, timelines, resources, and stakeholder communications.
- Lead and mentor clinical scientists and other junior clinical development professionals.
- Contribute to portfolio strategy, asset evaluation, business development, and clinical due diligence.
Do You Bring Proven Success in Neurology Drug Development Leadership?
- MD or recognized foreign medical equivalent is required.
- Completion of an accredited neurology residency is required.
- Board certification in neurology is required.
- At least 10 years of pharmaceutical or biotechnology clinical development experience is strongly preferred.
- At least 5 years of management or senior leadership experience in neurology clinical development is preferred.
- Demonstrated experience leading clinical drug development programs across multiple phases.
- Early-phase or first-in-human development experience is highly desirable.
- Strong medical monitoring, safety oversight, and clinical data interpretation experience.
- Experience designing clinical development plans and study protocols.
- Experience authoring or overseeing clinical content for regulatory submissions and development documents.
- Strong understanding of ICH-GCP, FDA expectations, and global clinical development requirements.
- Gene therapy clinical development experience is preferred.
- Direct experience with DMD or ALS is highly desirable.
- Pediatric neurology or pediatric clinical development experience is preferred.
- Experience managing clinical scientists or other clinical development professionals is preferred.
- Strong executive communication, cross-functional leadership, and scientific decision-making skills.
- Ability to support East Coast working hours while collaborating across U.S. time zones.
- Willingness to travel less than 15% domestically or internationally as needed.