Reporting to the Chief Medical Officer, this position is responsible for contributing to the overall strategy of the organization by bringing business solutions that support the organizationâ€™s value drivers. Provides strategic and operational leadership and content expertise in collaboration with Product Development, Commercial, Regulatory, Clinical Operations and other cross-functional team members, to ensure the design, as well as, the execution of the programs and related clinical activities, data analysis and communications required for the successful preparation and submission of INDs and NDAs.Â This position will develop and manage the budget and subsequent resource allocations required for the timely execution of the programs noted above.Â Â As the product pipeline continues to develop and support for the commercial launch of products is required, this position will define and with approval from the CMO, design and staff a clinical research team.Â This position is located in Emeryville, California.
- Medical Monitor for Adamas sponsored clinical trials
- Establish and approve scientific methods underlying the design and implementation of clinical protocols
- Organize and lead protocol steering committees
- Represent clinical research through membership on trial teams
- Develop study protocols in collaboration with the clinical operations department
- Adverse event safety monitoring and reporting
- Recruit, guide, and motivate clinical investigators
- Contribute to Clinical Study Reports, NDA reports, and other clinical/regulatory/safety documents
- Regularly reports to the executive management team key study metrics including, enrolment status, data quality and safety.Â If necessary, make recommendations for those studies which need to be re-evaluated, including the decision to halt/terminate a study.
- Ensure study compliance by understanding and applying all relevant SOPs and GCPs
- Present technical information to internal team and represent Adamas at externally through publications, presentations at scientific meetings, etc.
- Able to effectively plan, manage, and execute activities on time for multiple groups. Ensures planning is done well the first time to avoid inefficiencies in process. Anticipates and adjusts for problems and roadblocks.Â Measures performance of self and others against goals.
- Effective at establishing short and long range budgets and being financially responsible
- Participate in long range strategic product planning for current and future products
- Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations
- MD or MD/PhD in Neurology is required.Â Minimum 7 yearsâ€™ experience in design, execution and evaluation of clinical trials and new product submission documents, either in the specialty pharmaceutical or biopharmaceutical industry is essential. Complementary experience managing programs, projects, submissions and teams is also important.
- Substantive experience (3+ years) treating patients in a private practice, specialty neurology group or clinic. Responsibility for physician sponsored or commercially sponsored clinical trials is a plus.
- In depth understanding of pharmaceutical regulatory requirements and their impact on development of clinical trials and NDAs
- An active network in key segments of the CNS field.Â This will include KOLs, key research centers, patient advocacy groups and a variety of patient care organizations
- Able to provide multiple examples of creating and executing clinical studies and clinical trial protocols. In addition, responsibility for and substantial participation in constructing and preparing a variety of study reports, NDA reports and related documents.
- Able to write clearly and succinctly in a variety of communication settings. Open, transparent and succinct communication skills.
- Individual responsibility for communication of key study information to senior management. This will include enrollment status, data quality and adverse events (including frequency and resolution).
- Proven ability to effectively collaborate with Clinical Operations and other internal teams to build a variety of teams, both internal and external. Examples include internal trial teams, protocol steering committees, along with the selection and guidance of clinical sites and investigators.
- Background should include presentation of relevant technical and clinical information to internal teams, executive management, Board of Directors and selected external organizations
- Experience working with corporate and academic partners is a plus
- Ability to travel â€“ at times extensively
- Successful experience in fast-paced entrepreneurial environment
- Fit with Adamas culture and values
- Possesses unquestioned integrity and ethics. Always leads by example. Demonstrates a firm commitment to Adamasâ€™ values and culture. A positive attitude and source of energy to the company. Establishes trust and credibility with every individual he/she works with in this role.
- Creative and critical intellect with a â€śwhat ifâ€ť openness to new ideas. Generates ideas/opportunities and turns them into successful results.
- Able to productively challenge existing practices, decisions, and processes in a manner that generates constructive discussions/debates about change. Â Equally important, knows when the time to challenge must evolve into working to select and implement solutions.
- Appreciates and understands the need for good process. Able to effectively guide others in proper process development and execution.Â Seeks out and identifies areas that require systematic approaches in order to maximize efficiencies and build scalable processes.
- Results-oriented individual who conveys a sense of urgency and drives for closure.Â Able to execute and prioritize multiple, competing tasks and demands. Recognizes and executes critical details.
- Builds strong team orientation by creating an environment that encourages open exchange of ideas at all levels, across functions, departments, projects, and geographies
- Is effective in a variety of formal presentation settings. Presents well in internal meetings and external technical forums. Can change tactics midstream when something is not working. Can be a respected Adamas representative with external partners.
- Can effectively teach concepts and processes to others across the organization. Communicates results, outcomes or information appropriately, with regard to business needs and impact in a timely fashion.
- Able to lead key initiatives and achieve focus on key priorities. Provides clear direction, personally executes, delegates, communicates, and coaches/mentors as needed.
- Ability to convey complex concepts and strategies, on technical and non-technical topics, both orally and in writing. Excellent listener; seeks broad input and feedback, frequent and effective follow up.
To apply for this position please, send your resume toÂ email@example.comÂ with the job title in the subject line.Â Principals only, no recruiters please.