(Senior) Director Clinical Research

Seeking talent near: Princeton NJ San Diego CA

Position Summary

The (Senior) Director Clinical Research will be a highly qualified and motivated individual who will have a leadership role in the development of Acadia programs for rare diseases and/or neurologic and neuropsychiatric disorders. This person will have extensive clinical and scientific knowledge and a strong network in the medical community and successful experience in leading clinical programs.

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.

• Other duties as assigned.

Education and Experience

MD or equivalent required; Board Certified/Eligible strongly preferred. Targeting 3-5 years of relevant medical/clinical practice related research or academic experience within the pharmaceutical industry. Ideal candidate will have experience with medical monitoring including clinical research creating and implementing development plans and clinical studies. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Applicable industry experience across several phases of development is strongly desired.

• Established relationships with thought leaders and investigators in depression and other mood disorders.

• Experience in rare disease and/or neurology strongly preferred.

• Demonstrated leadership to work well within a geographically diverse cross-functional team environment.

• Ability to work within a growing organization within the U.S. and to help the organization evolve over time into the world leader inrare diseases and neurologic and neuropsychiatric disorders.

• Experience interacting with senior leaders including global regulatory agencies.

• Excellent verbal and written communication skills as well as interpersonal management and organizational skills.

• Demonstrated problem solving abilities and conflict resolution skills.

• Ability to engage in an open constructive and continuous dialogue with the Companys stakeholders.

• Highly motivated self-driven and dependable.

• Willing and able to travel both domestically and internationally.

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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