Executive Medical Director, Alzheimer’s Disease

Job Description:

NewAmsterdam is an innovative biotech company with experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related disorders. Over the last decade it has become apparent that one of the major risk factors for Alzheimer’s disease, Apolipoprotein E4, is closely associated with lipid dysregulation in the brain. Based on published data from a pre-specified analysis in our phase III BROADWAY trial evaluating Alzheimer’s disease biomarkers in patients with ASCVD, including patients with at least one ApoE4 allele, we are  excited to initiate a Alzheimer’s Disease clinical program. We are looking to recruit an Executive Medical Director, Alzheimer’s Disease to strengthen our team, which is led by a world-class team of industry veterans and key opinion leaders, including some of the world’s preeminent cardiometabolic experts.

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 Executive Medical Director, Alzheimer’s Disease position is a remote position based in either the United States or the Netherlands and will report to the Chief Development Officer.

Key Responsibilities

• 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 support 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 (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) 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, contract research organizations (CROs), and academic institutions, to exchange information, address study-related issues, and facilitate effective communication and collaboration throughout the clinical trial lifecycle.

• 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—and serve as a clinical research resource for—cross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development

• Contribute to (and may be asked to represent the clinical development department in) 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

Requirements

• 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 (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis, 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, evaluate study outcomes, and generate scientific evidence supporting product development, regulatory submissions, and evidence-based decision-making.

• 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 terms of handling complex, confidential, and regulated information

• Ability to travel approximately 20-25%

Salary and Benefits:

We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.

NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.