Associate Director Clinical Operations
Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease.
The Associate Director (AD) is a pivotal member of Alkahest’s Clinical Operations Team. Leading a team of clinical operations professionals, you will be responsible for the delivery of multiple studies and one or more clinical programs. In collaboration with the Head of Clinical Operations, the AD will influence and implement the clinical operations strategy and execution of the clinical development programs.
Alkahest offers a competitive compensation and benefits package, annual bonus potential, opportunities for career growth and development, and a work environment that is collaborative, collegial and fun.
The AD, Clinical Operations, will provide oversight for Clinical Operations activities for multiple clinical studies within one or more clinical programs. Your primary responsibilities will be to provide exceptional oversight of all aspects of study management in a largely outsourced clinical model, ensuring compliance with SOPs, GCP, and protocol requirements.
Specific responsibilities include, but are not limited to:
- Lead the start-up, ongoing day-to-day activities, close-out and reporting of assigned clinical studies
- Collaborate with functional representatives internally (e.g., Program Physician, Regulatory, Data Management, Medical Writing, Legal, Finance, Quality Assurance, etc.) as well as external vendors to ensure proper conduct and timely completion of all deliverables
- Act as the key sponsor representative in interactions with investigational sites, clinical consultants, Contract Research Organizations and other vendors
- Coordinate the development of protocols, informed consent forms, case report forms (CRFs), budgets, and study plans related to each study
- Provide oversight of service providers and vendors, including development and management of SOPs, Clinical Oversight Plans, documentation, training, co-monitoring, and other activities that lay the foundation of corporate GCP compliance
- Collaborate with Data Management to ensure the development of CRFs and related plans for the appropriate management and analysis of the data collected
- Assist in the writing of clinical study documents including IND/IDE supporting documents, status reports, and final clinical study reports
- Prepare and manage clinical study budgets and timelines ensuring on time execution within approved budget
- BS, BA in Life Sciences or related field
- Minimum 7 years clinical experience in a pharmaceutical or biotech with increasing levels of responsibility
- Capable of working in a fast-paced environment and taking initiative in seeking and utilizing available resources to effectively problem solve, all while ensuring the clinical trial is executed within compliance of regulations and of the highest quality
- Proactive in identifying areas of improvement to drive efficiency within Clinical Operations
- Knowledge of multiple aspects of the clinical research discipline, GCP, and ICH-E6 is essential
- Good interpersonal skills are a requirement
- Proficiency in MS Office (Word, Excel, Outlook)
Please send Cover Letter with CV.