Senior Medical Director, Clinical Development - Neuroscience

BioSpace; Kansas; Híbrido; USD 200.000 - 250.000; Jornada completa

Descripción de la vacante

A biotechnology company is seeking a Senior Medical Director to lead the clinical development of therapies for neuromuscular and neurodegenerative diseases. The ideal candidate will be a physician with extensive experience in clinical drug development and a passion for helping patients. Responsibilities include overseeing pivotal trials and collaborating with regulatory agencies. This role can be located at headquarters or have a hybrid/remote arrangement within the U.S.

Formación

• 5+ years (7+ years preferred) of biotech/pharma clinical development experience in neurological diseases.
• Experience across multiple stages of clinical development from IND to NDA/BLA.
• Legal authorization to work in the US without sponsorship.

Responsabilidades

• Lead strategy, development, and execution of clinical research programs.
• Design trials for Phase I/II/III research targeting neurologic diseases.
• Collaborate with regulatory affairs on IND, CTA, and NDA submissions.

Conocimientos

Clinical development experience in neurological diseases

Interpersonal skills

Public speaking skills

Ability to work in a matrix environment

Educación

M.D. or equivalent degree

Formal Neurology training

Descripción del empleo

Overview

Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has a robust preclinical pipeline of PROTAC protein degraders against validated and “undruggable” targets, and three investigational clinical-stage programs currently enrolling: ARV-102 for neurodegenerative disorders, ARV-393 for relapsed/refractory non-Hodgkin Lymphoma and potentially other lymphomas, and ARV-806, a KRAS G12D PROTAC for solid tumors with KRAS G12D mutations. In 2025, the FDA accepted the NDA for vepdegestrant, an investigational, orally bioavailable PROTAC estrogen receptor degrader, for use as monotherapy in adults with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine therapy; Arvinas and Pfizer announced plans to jointly select a third party for out-licensing and commercialization of vepdegestrant. In 2024, Arvinas entered into a global license agreement with Novartis for the development and commercialization of ARV-766 for prostate cancer, with the transaction closing in 2024.

#TeamArvinas is made up of passionate and curious employees whose diverse thoughts and perspectives are valued. Employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission—to improve the lives of patients with serious diseases by pioneering therapies created with our PROTAC protein degradation platform. Learn more about life at Arvinas and what employees have to say at www.arvinas.com.

Position Summary

Arvinas is looking for an experienced Senior Medical Director with the passion and creativity to develop great medicines for neuromuscular and neurodegenerative diseases. The ideal candidate is a physician with global drug development program and global filing experience who is enthusiastic about applying their knowledge to patients around the globe who have no approved therapies for their disease. The individual will be a self-starter with excellent management and leadership capabilities who seeks to lead and be part of an innovative team that will drive drug development from start to finish. Reporting into the Vice President of Clinical Research, the Senior Medical Director will be responsible for the strategy, development and execution of clinical research and development programs, including leadership of pivotal trials and filing activities. This position will serve as a key liaison between the company and clinical investigators, and will establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners. The successful candidate will be ready for a career-defining experience and have the passion to drive therapeutics for serious diseases to final approval. This role can be located at the New Haven, CT headquarters or with a hybrid or remote work arrangement within the U.S.

Principal Responsibilities

• Partner with discovery and biology leadership to provide clinical input and guidance for neuroscience strategy.
• Design trials for Phase I/II/III research targeting neurologic diseases, with expertise in CNS/Neurology and trial stewardship.
• Directly supervise and monitor trial conduct.
• Work with all functions and external partners to manage trial execution and investigators’ engagement.
• Collaborate on global regulatory plans and participate in regulatory meetings with regulatory affairs; identify opportunities for external collaboration.
• Monitor developments in the scientific literature and maintain external expert contacts to support understanding of candidate drug effects and strategic insights for study and program development.
• Develop effective relationships with external providers.
• Provide clinical assessments of potential in-licensing assets and identify novel therapeutic opportunities as well as design and execution challenges.
• Review written materials and provide editorial comments for clinical study reports and manuscripts.
• Ensure ethical standards in compliance with internal SOPs, local regulations, and laws.

Additional Responsibilities

• Design and develop clinical study protocols and associated documents; monitor documentation in compliance with clinical development plans, GCP, and good medical practice.
• Assist in selecting clinical investigators and provide guidance to investigators on studies.
• Provide medical supervision for CROs and protocol procedures.
• Provide medical and scientific input on review of clinical data, safety data, and laboratory values; assess safety profile and efficacy data as appropriate.
• Provide medical surveillance on Serious Adverse Event (SAE) reporting and follow-ups.
• Oversee strategy for clinical drug product development; collaborate with Regulatory on IND, CTA, NDA submissions and safety reports.
• Lead clinical interactions with regulatory agencies worldwide.
• Participate in planning, writing, and reviewing Clinical Study Reports, regulatory updates, and submissions.
• Assist with due diligence of new scientific developments.
• Analyze and interpret study data for abstracts or publications as required.
• Support corporate partnering and business development with medical expertise and participation in partnership committees/task groups.
• Collaborate on overall company strategy and licensing of new programs.
• Support budgeting and timelines with the finance group as needed.
• Plan and lead clinical focus groups to inform trial and protocol designs.
• Ensure operational activities comply with regulatory requirements and company standards.
• Lead medical writing for summarization of clinical trial data, including study reports and labeling.

Qualifications

• 5+ years (7+ years strongly preferred) of biotech/pharma clinical development experience in neurological diseases.
• Experience across multiple stages of clinical development, from IND to NDA/BLA.
• Global clinical development and filing experience preferred.
• Technical medical and scientific experience evaluating targets/agents for licensing or development.
• Experience supervising physicians and/or scientific staff in a leadership role is desirable.
• Excellent interpersonal and public speaking skills for a high-visibility role.
• Ability to work in a matrix, cross-functional environment.
• Legal authorization to work in the US without sponsorship now or in the future.
• Role commonly conducted in a home office environment with equipment for communication and collaboration.

Education

• M.D. or equivalent degree required; formal Neurology training required.

Arvinas is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.