BioSpace
Senior Director, Clinical Scientist -Neurodegenerative disease
BioSpace, Topeka, Kansas, United States
Senior Director, Clinical Scientist - Neurodegenerative disease
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. The company uses its proprietary PROTAC Discovery Engine platform to engineer proteolysis‑targeting chimeras that selectively degrade and remove disease‑causing proteins. Arvinas has a robust preclinical pipeline and three investigational clinical‑stage programs: ARV‑102 for neurodegenerative disorders, ARV‑393 for relapsed/refractory non‑Hodgkin Lymphoma, and ARV‑806 for KRAS G12D‑mutated solid tumors. Recent milestones include FDA approval of the NDA for vepdegestrant and strategic partnerships with Pfizer and Novartis.
#TeamArvinas values diverse perspectives, innovation, and a commitment to improving patient outcomes. Learn more about life at Arvinas on our website.
Position Summary The Clinical Scientist provides scientific support for all Global Clinical Development activities, including data evaluation, scientific writing, and strategic input to clinical documents and presentations. The role requires clear communication, independent thinking, and deep knowledge of clinical drug development processes.
Principal Responsibilities Clinical Document Development
Lead development of clinical study protocol synopses and full protocols, engaging subject matter experts on design and endpoints.
Contribute to investigator brochure reviews, clinical study reports, DSURs, annual reports, and regulatory briefing books.
Manage internal and external presentations and publications, and support publication planning.
Contribute to writing departmental SOPs, templates, and processes.
Clinical Study Planning
Assist clinical research physicians in developing clinical development plans.
Contribute to data collection tools, SAPs, and CRFs.
Collaborate with cross‑functional teams to ensure timely study start‑up, including CRO selection and central lab onboarding.
Study Data Review and Analysis
Lead development of Medical Monitor Plans.
Perform ongoing clinical data review and critical analysis.
Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data Management, and biostatisticians to ensure quality and timely study conduct.
Support leadership, advisory board meetings, and data summaries.
Review of Scientific Literature
Conduct literature searches, review, and summarize relevant scientific and medical literature for document development.
Provide scientific/medical materials to in‑house staff and external consultants.
Identify literature addressing specific topics relevant to Arvinas drug candidates.
Qualifications Required:
Advanced, doctoral‑level degree (PhD, MD, MSc/MPH, PharmD, or equivalent) – preferred.
10+ years of experience in a pharmaceutical company environment.
Experience and educational background in neurodegenerative or neuromuscular disease.
Advanced knowledge of GCP/ICH, drug development, study design, statistics, and clinical operations in the neurodegenerative/neuromuscular setting.
Excellent project management, communication, and organizational skills.
Strong team player with a passion for scientific discovery.
Ability to work independently and deliver high‑quality objectives on time.
Note: Arvinas will not provide VISA sponsorship now or in the future. Candidates must be authorized to work in the U.S. without sponsorship.
Benefits Arvinas offers a competitive package of base and incentive compensation plus a comprehensive benefits program, including group medical, vision, and dental coverage, life insurance, and more. Benefits are designed to support the health, wellness, and financial security of employees and families.
Equal Opportunity Employer 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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Health Care Provider
Internet News
#J-18808-Ljbffr
#TeamArvinas values diverse perspectives, innovation, and a commitment to improving patient outcomes. Learn more about life at Arvinas on our website.
Position Summary The Clinical Scientist provides scientific support for all Global Clinical Development activities, including data evaluation, scientific writing, and strategic input to clinical documents and presentations. The role requires clear communication, independent thinking, and deep knowledge of clinical drug development processes.
Principal Responsibilities Clinical Document Development
Lead development of clinical study protocol synopses and full protocols, engaging subject matter experts on design and endpoints.
Contribute to investigator brochure reviews, clinical study reports, DSURs, annual reports, and regulatory briefing books.
Manage internal and external presentations and publications, and support publication planning.
Contribute to writing departmental SOPs, templates, and processes.
Clinical Study Planning
Assist clinical research physicians in developing clinical development plans.
Contribute to data collection tools, SAPs, and CRFs.
Collaborate with cross‑functional teams to ensure timely study start‑up, including CRO selection and central lab onboarding.
Study Data Review and Analysis
Lead development of Medical Monitor Plans.
Perform ongoing clinical data review and critical analysis.
Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data Management, and biostatisticians to ensure quality and timely study conduct.
Support leadership, advisory board meetings, and data summaries.
Review of Scientific Literature
Conduct literature searches, review, and summarize relevant scientific and medical literature for document development.
Provide scientific/medical materials to in‑house staff and external consultants.
Identify literature addressing specific topics relevant to Arvinas drug candidates.
Qualifications Required:
Advanced, doctoral‑level degree (PhD, MD, MSc/MPH, PharmD, or equivalent) – preferred.
10+ years of experience in a pharmaceutical company environment.
Experience and educational background in neurodegenerative or neuromuscular disease.
Advanced knowledge of GCP/ICH, drug development, study design, statistics, and clinical operations in the neurodegenerative/neuromuscular setting.
Excellent project management, communication, and organizational skills.
Strong team player with a passion for scientific discovery.
Ability to work independently and deliver high‑quality objectives on time.
Note: Arvinas will not provide VISA sponsorship now or in the future. Candidates must be authorized to work in the U.S. without sponsorship.
Benefits Arvinas offers a competitive package of base and incentive compensation plus a comprehensive benefits program, including group medical, vision, and dental coverage, life insurance, and more. Benefits are designed to support the health, wellness, and financial security of employees and families.
Equal Opportunity Employer 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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Health Care Provider
Internet News
#J-18808-Ljbffr