Job Summary: Reporting to the Executive Medical Director, the Senior Medical Director will serve as the clinical development leader for one or more pipeline products. This person will serve as the key development representative on project teams to support clinical development from asset identification through commercialization and beyond. The Senior Medical Director will collaborate with cross-functional team members, including Clinical Sciences, Clinical Operations, Program Management, Biostatistics and Data Management, Safety and Pharmacovigilance, DMPK/Clinical Pharmacology and CRO partners.
Primary Responsibilities:- Serve as the Development Leader and represent Clinical Development on Program and Project Strategy Teams.
- Collaborate with the Project Team Leader(s) and other team members to create and revise the Clinical Development Plan (CDP) for successful global regulatory approval and market access for one or more indications and develop and execute the clinical strategy.
- Lead the design of scientifically rigorous clinical protocols that are aligned with the clinical development plan.
- Provide clinical development leadership on the timely delivery of the clinical program with attention to quality and scientific rigor.
- Lead and support the clinical components of key documents (e.g., Clinical Trial Protocols, Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including INDs/CTAs, NDAs/MAAs and regulatory responses) with high quality and consistency with the CDP.
- Oversee the Medical Monitor and/or Medical Director(s) and work in concert with the Head of Safety to ensure continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection.
- Collaborate with biostatistics, clinical sciences, and other applicable team members to participate in relevant and timely data analyses and presentations for safety monitoring committee meetings, regulatory documents and internal reviews to support timely program decisions regarding study objectives.
- Lead and/or participate in interactions with internal decision committees and external stakeholders including regulatory authorities, key opinion leaders (KOLs), data monitoring committees, advisory boards, patient advocacy groups.
- Support and oversee the periodic convocation of Steering Committee(s), as applicable.
- Work with the internal team to develop and update key messages on disease states, MOA, target product profile, and scientific platform.
- Collaborate with Medical Affairs and other team members on scientific communication of clinical data, including external messaging, publication planning, and congress management.
- Work with investigators, KOLs, patient advocacy groups, and other external stakeholders, as appropriate, to foster scientific exchange, to identify collaboration opportunities, to recruit patients for clinical trials, and to support commercial planning, including understanding of medical and health care practices.
- Represent the company as an organization and present data at advisory boards, investigator meetings, congresses, and other external venues.
- Author and review abstracts, posters, and manuscripts for publication.
Qualifications:To succeed in this role, the candidate must have a genuine interest and understanding of the science supporting the pipeline, an ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and an innovative drive to help the organization to succeed and develop new therapies for patients with unmet medical needs. In addition, strong communication skills and proven proficiency in understanding, analyzing, and presenting scientific and clinical data are critical.
- Medical Doctor (MD or equivalent); Board Certification in Neurology a plus.
- Minimum of 5 years of clinical development experience in the pharmaceutical or biotechnology industries.
- Understanding of clinical trial design, methodology, statistical concepts, protocol development and implementation, global regulatory submissions, and overall drug development.
- Track record of success in serving as a clinical development leader on cross-functional product teams.
- Outstanding analytical, problem-solving, organizational and communication skills.
- Ability to travel up to 20% required.
- Ability to work a hybrid schedule in office at least 3 days per week is required.
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$317,000-$369,000 USD
