Sr. Director of Clinical Science

Position Summary:

Performs a key role in the future development for products in development. Responsible for various aspects and oversight for clinical trials. Overall responsibility encompasses abstract submission, investigator meetings and Scientific Advisory Boards. Reports to the VP, External  Innovation .

Primary Responsibilities:

• Responsible for all scientific aspects of conceptualizing and planning trials
• Provides high level input to clinical trial protocol design and clinical study
• Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biostatistics and Data Management, Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines
• Provides ongoing clinical monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management, and drug safety
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as ACADIA'S SOPs 
• Manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans
• Consolidates the collection and assimilation of ongoing data for internal analysis 
• Organizes and manages the preparation and/or review of data listings, summary tables, study results and scientific presentation.
• Presents scientific information at scientific conferences as well as clinical study investigator
• Evaluates safety and efficacy data
• Analyzes and summarizes data for presentation to senior management and regulatory agencies
• Serves as a resource to other functions in evaluating business development opportunities
• Provides assistance and support in managing relationships with regulatory affairs & biometrics

 Education/Experience/Skills:

PhD, MD, PharmD, or equivalent combination of relevant education and applicable job experience may be considered. A minimum of 12 years' progressively responsible related experience in pharmaceutical clinical research in Central Nervous System disorders is required with a minimum of 8 years' in a leadership role. A minimum of 3 years progressively responsible experience in clinical research. Experience of Neurology, Psychiatry or Psychology would be advantageous.

Must possess:

• Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical
• Excellent scientific written and oral communication
• A proven ability to work highly effectively with multiple
• The ability to work with attention to detail in a time sensitive
• Excellent technical/scientific communication skills (both verbal and written)
• Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines
• Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is
• Comfortable discussing with experts and opinion leaders the science and research approaches that are critical for study protocol design, clinical endpoints and data interpretation
• Strategic thinking skills with the ability to formulate, develop and execute clinical
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals

Scope:

Establishes strategic plans for designated function(s) and may participate with senior management to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of functional area and may impact the long-term success of the company.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 25% of the time and work  after  hours if required by travel schedule or business issues.

ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity