1+ months

Associate Director, Clinical Science

ACADIA Pharmaceuticals
Princeton, NJ 08540
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  • Job Code
    114673608
ACADIA Pharmaceuticals

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

The Associate Director, Clinical Science will be a highly qualified and motivated individual who enjoys collaborative, data-driven problem solving in a clinical trial setting. The individual will serve on cross-functional teams to advance the development of compounds for CNS disorders. This position reports to a Development Lead, and will support multiple programs and will be responsible for implementing clinical development plans consistent with the Companys strategic vision and mission.

Primary Responsibilities:

  • Collaborates with matrix team to ensure optimal planning and implementation of clinical studies
    • Input and collaboration with the medical leads on clinical trial protocol development
    • Collaborates with Operations to oversee feasibility assessments for new clinical trials
    • Provides high level study-related scientific and clinical guidance to staff, external partners, and Investigators
    • Collaborates with internal and external partners to develop and implement the overall data quality plan including but not limited to eligibility criteria and signal detection
    • Collaborates with Development Lead, Medical Monitor, and Operations personnel to ensure proper monitoring and oversight of trials
    • Utilizes relevant metrics and other reporting tools to evaluate study strategy, tactics, deliverables and timelines
    • Contributes to the preparation/review of regulatory documents, periodic reports, Investigator Brochures and development plans.
    • Develops agendas, materials and other documents for internal and external meetings pertaining to assigned studies and programs
    • Interacts frequently with investigative sites, including site visits and investigator meetings
    • Collaborates with Operations to overcome operational challenges during study implementation, including providing scientific guidance for study recruitment and retention initiatives
    • Conducts appropriate literature searches, and stays current with scientific literature
    • Communicates study issues appropriately to management
  • Collaborates cross-functionally to evaluate, interpret, report and present study data
    • Organizes and manages the preparation and/or review of data listings, summary tables, and study results
    • Identifies and evaluates study data trends, outliers, protocol violators, etc.
    • Contributes to the writing of final study reports
    • Presents updates and results to study teams and management
    • Presents at scientific conferences and other external meetings.
  • Serves as a resource to other functions in evaluating business development opportunities.
  • Provides assistance and support in managing relationships with regulatory affairs, biometrics and other non-clinical departments
  • Promotes a high performance culture and respectful work environment
  • Complies with all applicable laws, regulations, industry standards of Good Clinical Practice, and ACADIAs SOPs.

Education/Experience/Skills:

PharmD, MD, or PhD or equivalent combination of relevant education and applicable job experience may be considered. A minimum of 7 years progressively responsible experience in clinical research is required. Experience within Neurology, Psychiatry, Geriatrics, or Psychology is preferred.

Must possess:

  • Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical research, including a track record of competing for independent research funding (e.g., grant funding) is a plus.
  • Excellent technical/scientific written and oral communication skills.
  • A proven ability to work highly effectively with multiple departments.
  • The ability to work independently with attention to detail in a time sensitive environment.
  • Excellent interpersonal skills with ability to lead, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Comfortable being a trusted resource for team members with varying work backgrounds and levels of expertise
  • Strong familiarity with the drug approval process (including applicable regulations), Good Clinical Practices and International Conference on Harmonization Guidelines is preferred.
  • Comfortable discussing with experts, opinion leaders and senior level leaders the scientific 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 strategies.
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
  • Previous data management, statistical modeling or programming skills (e.g., R, SAS, Python, MATLAB, VBA, J-Review) desirable
  • Ability to travel <30%

Scope:

Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.

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.


PI114673608

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p>The Associate Director, Clinical Science will be a highly qualified and motivated individual who enjoys collaborative, data-driven problem solving in a clinical trial setting. The individual will serve on cross-functional teams to advance the development of compounds for CNS disorders. This position reports to a Development Lead, and will support multiple programs and will be responsible for implementing clinical development plans consistent with the Companys strategic vision and mission.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Collaborates with matrix team to ensure optimal planning and implementation of clinical studies <ul> <li>Input and collaboration with the medical leads on clinical trial protocol development</li> <li>Collaborates with Operations to oversee feasibility assessments for new clinical trials</li> <li>Provides high level study-related scientific and clinical guidance to staff, external partners, and Investigators</li> <li>Collaborates with internal and external partners to develop and implement the overall data quality plan including but not limited to eligibility criteria and signal detection</li> <li>Collaborates with Development Lead, Medical Monitor, and Operations personnel to ensure proper monitoring and oversight of trials</li> <li>Utilizes relevant metrics and other reporting tools to evaluate study strategy, tactics, deliverables and timelines</li> <li>Contributes to the preparation/review of regulatory documents, periodic reports, Investigator Brochures and development plans.</li> <li>Develops agendas, materials and other documents for internal and external meetings pertaining to assigned studies and programs</li> <li>Interacts frequently with investigative sites, including site visits and investigator meetings</li> <li>Collaborates with Operations to overcome operational challenges during study implementation, including providing scientific guidance for study recruitment and retention initiatives</li> <li>Conducts appropriate literature searches, and stays current with scientific literature</li> <li>Communicates study issues appropriately to management</li> </ul> </li> <li>Collaborates cross-functionally to evaluate, interpret, report and present study data <ul> <li>Organizes and manages the preparation and/or review of data listings, summary tables, and study results</li> <li>Identifies and evaluates study data trends, outliers, protocol violators, etc.</li> <li>Contributes to the writing of final study reports</li> <li>Presents updates and results to study teams and management</li> <li>Presents at scientific conferences and other external meetings.</li> </ul> </li> <li>Serves as a resource to other functions in evaluating business development opportunities.</li> <li>Provides assistance and support in managing relationships with regulatory affairs, biometrics and other non-clinical departments</li> <li>Promotes a high performance culture and respectful work environment</li> <li>Complies with all applicable laws, regulations, industry standards of Good Clinical Practice, and ACADIAs SOPs.</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <p>PharmD, MD, or PhD or equivalent combination of relevant education and applicable job experience may be considered. A minimum of 7 years progressively responsible experience in clinical research is required. Experience within Neurology, Psychiatry, Geriatrics, or Psychology is preferred.</p> <p>Must possess:</p> <ul> <li>Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical research, including a track record of competing for independent research funding (e.g., grant funding) is a plus.</li> <li>Excellent technical/scientific written and oral communication skills.</li> <li>A proven ability to work highly effectively with multiple departments.</li> <li>The ability to work independently with attention to detail in a time sensitive environment.</li> <li>Excellent interpersonal skills with ability to lead, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.</li> <li>Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)</li> <li>Comfortable being a trusted resource for team members with varying work backgrounds and levels of expertise</li> <li>Strong familiarity with the drug approval process (including applicable regulations), Good Clinical Practices and International Conference on Harmonization Guidelines is preferred.</li> <li>Comfortable discussing with experts, opinion leaders and senior level leaders the scientific and research approaches that are critical for study protocol design, clinical endpoints and data interpretation.</li> <li>Strategic thinking skills with the ability to formulate develop and execute clinical strategies.</li> <li>Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.</li> <li>Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.</li> <li>Previous data management, statistical modeling or programming skills (e.g., R, SAS, Python, MATLAB, VBA, J-Review) desirable</li> <li>Ability to travel <30%</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.</p> <p><strong><u>Physical Requirements:</u></strong></p> <p>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. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/p7ey7PiQkNKyF2o5fdwqn"> <p>PI114673608</p>
Posted: 2019-10-18 Expires: 2019-11-19

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Associate Director, Clinical Science

ACADIA Pharmaceuticals
Princeton, NJ 08540

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