Reports to : VP Clinical Development
Alkahest is a clinical-stage biopharmaceutical company focused on treating age-related diseases by developing therapies that counteract the aging plasma proteome.
By targeting the body’s chronokines, proteins that increase or decrease with age, our therapeutic candidates address the complex pathology underlying Alzheimer’s disease, Parkinson’s disease, Age-
related Macular Degeneration and other neurodegenerative diseases and diseases of aging.
Summary & Scope of Position :
The Medical Director / Senior Medical Director will be responsible for the clinical strategy in ophthalmology, including indication selection, design of trials in AMD and other indications, and ongoing medical monitoring of safety signals in ophthalmology trials.
Primary Responsibilities :
Design of AMD trials, including study population and eligibility criteria, treatment duration, clinical endpoints, biomarkers, and safety mitigation strategy
Serve as the Program Physician for all AMD clinical trials, addressing patient eligibility and treatment questions in collaboration with the contract research organization (CRO) medical monitor, or directly with study investigators;
Work closely with preclinical scientists to understand how the biological effects observed in animals can be translated to humans, and use this information to choose the best clinical endpoints and biomarkers for clinical trials;
Be familiar with the nonclinical safety data (toxicology) and use this information to develop safety mitigation strategies in clinical trial design;
Serve as a key part of the cross-functional project team, supporting the overall strategy, budget, timeline of the project
Review safety data for individual subjects and trend review for safety signals from ongoing trials;
Interpret, summarize and present data from clinical trials to the company and externally
Provide strategic input for clinical development plans and regulatory strategy
Provide input / review of clinical documents, e.g. protocols, investigator’s brochures, case report forms
Participate in site / investigator identification and evaluation for clinical trials; conduct site engagement calls and visits
Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions
Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources
Provide and enhance knowledge in the ophthalmology therapeutic area to support global clinical development plans
Represent the company at scientific meetings and presentations
Attend and provide medical support for investigator and consultant meetings and clinical advisory boards
Develop and manage relationships with key opinion leaders to obtain advice and feedback
Medical Degree with completed residency training in ophthalmology and at least 2 years of post-residency clinical experience
Ideally, subspecialty training in retina and / or retina clinical experience and / or drug development experience in retinal diseases
Minimum 3 years of experience in the pharmaceutical or biotech industry, either in early clinical development / translational medicine or in pivotal development
Hands-on experience with clinical trial design, trial conduct and oversight, including medical monitoring
Knowledgeable in GCP guidelines in US and Europe
Team player with good oral presentation and written skills
Collaborative and flexible in personal interactions
Ability to work proactively and effectively, with exceptional problem-solving skills
Up to 25% travel
If you have the work ethic and mental agility to embrace a fast-paced and rapidly evolving environment, you will be rewarded with diverse and exciting experiences.
This is your chance to add real value to an entrepreneurial organization that supports bold innovation and new ideas. Alkahest welcomes passionate, team-
oriented colleagues who are looking to improve the health of patients worldwide by developing a deeper understanding of age-related disease.