ADS-4101 is an investigational high-dose lacosamide, to be taken once-daily at bedtime. Lacosamide is an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB as VIMPAT® (lacosamide).

Epilepsy affects an estimated 2.2 million Americans, of which 60% have partial onset seizures. Monotherapy treatment of partial seizures is effective in approximately 60% of patients, leaving the remainder of patients to require adjunctive treatment with one or more additional anticonvulsant therapies. There are limited data on the temporal distribution of seizures over the 24-hour day. However, data from published studies and from a study conducted by Adamas suggest that seizures occur in a diurnal pattern, characterized by a peak between 8 AM and 4 PM, and lowest between midnight and 8 AM. Thus, by matching the timing pattern of seizures to the concentration of the anti-epileptic drug, with a higher drug concentration during the day and lower drug concentration during the night, may enable improved seizure control.

Clinical studies of lacosamide have demonstrated dose limitations due to dizziness immediately following administration. We hypothesized the dizziness associated with higher doses might be in part attributed to the rapid initial rate-of-rise in drug concentration. Adamas scientists confirmed this time-dependent effect through in vivo modelling and pre-clinical experiments, showing that tolerability was dependent on rate -of-rise of drug concentration and not on maximum concentrations (Cmax).

We designed ADS-4101 to have an [attenuated/ tempered] initial rate-of-rise in lacosamide concentrations, to potentially improve the adverse event profile. This slow initial rise, enables a higher once-daily nighttime dose, resulting in a higher daytime concentration that may be more effective for patients then VIMPAT.

The data from a Phase 1 study of 24 healthy volunteers showed that a single 400 mg dose of ADS-4101 have improved tolerability compared to the equivalent dose of VIMPAT (lacosamide) immediate-release (IR) tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced initial rate-of-rise and prolonged time to maximum drug concentration (Tmax) appropriate for nighttime dosing.

We are currently conducting a multi-dose Phase 1b study designed to evaluate the tolerability and pharmacokinetic profile of three ascending doses of ADS-4101 (up to 600 mg/day) taken once-daily at bedtime compared to ascending doses of twice daily VIMPAT tablets in 24 healthy volunteers. Topline data from the study is expected in the third quarter of 2017.

Clinical Program Director

The Clinical Program Director plays a critical role in developing and managing the clinical operations team and infrastructure for a given project(s). This position will provide strategic and operational leadership and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality and risk mitigation. This position is based in Emeryville, CA and reports to the Vice President, Clinical Operations.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Publications and Scientific Communications

The Director, Publications and Scientific Communications, is responsible for all the R&D deliverables: including the scientific platform and its derivatives: abstracts, posters, manuscripts, and other collateral (e.g., videos, master slide decks). This position reports to the Vice President, Research and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Regulatory Affairs Development

The Director, Development Regulatory Affairs ensures that regulatory expertise is provided for all investigational drug development programs to enable product registration. The incumbent will be an effective collaborator with the research, clinical research, clinical operations, pharmaceutical development, and quality departments. This position reports to the Vice President, Regulatory Affairs and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Science Liaison / Sr. Medical Science Liaison - Dallas, TX

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Science Liaison / Sr. Medical Science Liaison - Philadelphia, PA

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Clinical Research Associate

The Senior Clinical Research Associate (Sr. CRA) will be responsible for ensuring high quality execution of single and multi-site clinical studies, across all Phases, according to the protocols, while adhering to GCP/ICH, and to Adamas Pharmaceutical Inc. SOPs within reasonable limits of time and budget. Reports to the Director, Clinical Operations.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Counsel, Healthcare Law

The Senior Counsel, Healthcare Law, will support legal matters related to the strategy and execution of commercial, medical, and clinical activities. This position reports to the Assistant General Counsel and is expected to work closely with other members of the legal and compliance group, as well as executive, commercial, medical, regulatory, and clinical teams. This position is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Manager, Pre-commercial Quality Assurance

The Senior Manager, Pre-commercial Quality Assurance is responsible for managing quality operations at Adamas Contract Service Providers of clinical drug substance, drug product, packagers and distribution to ensure that CSP are in compliance with applicable regulations, Quality Agreements (QA), and Standard Operating Procedures (SOP’s). In addition will provide Quality support to all Development Project Teams. This position will report to the Vice President of Quality Assurance and is based in Emeryville, CA.

Responsibilities:

Qualifications:

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.