[Hiring] Executive Medical Director, Alzheimer’s Disease @NewAmsterdam Pharma Corporation

Role Description

The Executive Medical Director, Alzheimer’s Disease will lead the design, monitoring, data analysis, and interpretation of the Company’s clinical trials in Alzheimer’s Disease. As such, the Executive Medical Director, Alzheimer’s Disease is a critically important and visible member of the clinical development team. The position is remote and will report to the Chief Development Officer.

• Lead the formulation and implementation of the Clinical Development Plan while taking into consideration the strategic objectives.
• For clinical trials:
  • Protocol design: lead the clinical trial design to ensure the design supports the strategic objectives.
  • Work with CRO medical monitors and sites to review and respond to site queries related to protocols, such as eligibility criteria, adverse event questions, drug administration, etc.
  • Support the PV department in oversight of the medical & safety monitoring conducted by the CRO.
  • Ensure successful completion of trial-related documents with cross-functional team members.
  • Support site and subject retention.
  • Analyze, evaluate, interpret, and report clinical data.
  • Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions.
  • Provide clinical science related leadership to study teams.
  • Contribute to ad-board meetings, executive committee meetings.
  • Responsible for high quality collaboration with external stakeholders, including thought leaders, clinical investigators, regulatory agencies, CROs, and academic institutions.
  • Contribute to regulatory strategy and development of sections of the IB.
  • Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance.
  • Collaborate with cross-functional colleagues to optimize product development.
  • Contribute to corporate strategic and organizational initiatives.
  • Assist in portfolio management and commercial activities as needed.
  • Adhere to rigorous ethical standards.
  • Travel as required both domestically and internationally for scientific meetings.

Qualifications

• M.D. degree: Completion of ACGME-accredited residency and fellowship strongly preferred.
• Board-certified required, with specialty in Neurology.
• Physician licensure in at least one state strongly preferred if based in US.
• At least 8-10 years of industry experience (minimum of 5 years in clinical trial design and execution).
• Thorough knowledge of clinical trials design, processes and GCP and ICH guidelines.
• Working knowledge of US FDA and EMEA AD related regulations and guidelines.
• Ability to perform literature research, analyze and author clinical trial publications.
• Robust analytical skills to analyze and interpret clinical trial data.
• Comfortable in communicating and interacting with investigators, KOLs, and advisors.
• Multi-task while remaining organized and attentive to detail.
• High work ethic, a trustworthy and collaborative team player.
• Demonstrate sound judgement in handling complex, confidential, and regulated information.
• Ability to travel approximately 20-25%.

Benefits

• Competitive base salary.
• Annual bonus and long-term incentives.
• Comprehensive benefits package, including health insurance, dental and vision coverage.
• Term life and disability coverage.
• Retirement plans.