Senior Director, Clinical Development
San Diego, CA - USA
Job Summary
Please note that this position can be based in San Diego CA; Princeton NJ; San Francisco CA. Acadias hybrid model requires this role to work in our office an average of 3 days per week.
Position Summary
Primary Responsibilities
- Create and execute global clinical development plans consistent with the Companys strategic vision and mission
- Ensure the optimal planning implementation and interpretation of clinical studies including synopsis/protocol development medical monitoring data analysis and writing of final reports
- Maintain and build productive relationships with investigators thought leaders and centers of excellence across the scientific community as well as with colleagues across the Acadia organization
- Interact frequently with sites to support study awareness patient recruitment and quality of study conduct
- Communicate appropriate program issues and results to key internal and external stakeholders
- Support regulatory interactions including the submission of regulatory documents and presentations
- Provide clear and insightful clinical and scientific expertise to advance the successful transition of compounds from discovery to full development and subsequently to life cycle management
- Review business development opportunities translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements
- Comply with current local and international regulations laws scientific and regulatory guidance Good Clinical Practices and Acadias policies and procedures
Education/Experience/Skills
- MD MD-PhD or equivalent medical degree required;Board Certified or Board Eligible in Psychiatry or Neurology
- Minimum 5 years applicable industry across several phases of development is desired
- CNS clinical research experience is required including demonstrable experience in successfully creating and implementing development plans and clinical studies; demonstrable experience in neurodegenerative and / or psychiatric disorders is preferred
- Established relationships with thought leaders and investigators in neurodegenerative and / or psychiatric disorders and other mood disorders
- Demonstrated ability to work well within a geographically diverse team structure
- Ability to work within a growing organization within the U.S. and to help the organization evolve over time into the world leader in psychiatry and neurology thereby improving the quality of life of those suffering from central nervous system disorders
- Ability to engage in an open constructive and continuous dialogue with the Companys stakeholders based on equality and mutual respect; transparency is critical and a key element to success
- Effective oral and written communication skills
- Highly motivated self-driven and dependable
- Ability to travel domestically and internationally as business needs require
Physical Requirements
This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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Required Experience:
Exec
About Company
For 30 years, Acadia has been working at the forefront of healthcare to protect what makes you, uniquely you. This is our purpose.