25 days old

Temporary Associate Director, Clinical Project Management

ACADIA Pharmaceuticals
Princeton, NJ 08540
  • Job Code
    114674450
ACADIA Pharmaceuticals

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

Position Summary: Provide project support in managing multiple cross functional workstreams in support of sNDA and therapeutic area program deliverables. Responsible for the communication of project status and issues while ensuring corporate goals in collaboration with the program team are met on time.

Primary Responsibilities:

  • Regulatory Submission: Collaborate with PM Lead/ Regulatory Lead in the management of integrated timeline and coordination of cross functional deliverables in support of sNDA submission.
  • Timeline Management: Assist with managing project timelines to plan with a clear understanding of functional interdependencies and critical path activities.
  • Project Reporting: Lead consolidation of project status reports including dashboards and other metric tools to monitor progress against milestone targets.
  • Risk Management: Work closely with PM in developing, monitoring and managing of project related risks as well as providing support in defining and implementation of mitigation and contingency plans.
  • Relationships: Develop relationships and interact cross functionally as well as with all levels of management

Education/Experience/Skills:

  • Bachelors degree in life sciences and/or combination of education/experience
  • Minimum 8-10 years of progressively responsible, relevant experience focusing on project management which includes experience managing cross-functional project teams.

Must possess:

  • Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail.
  • Experience supporting regulatory submissions i.e., IND, NDA, sNDA and BLA
  • Familiarity with FDA and/or EMA Regulations, ICH Guidelines, and GXPs governing the conduct of clinical trials is required.
  • A solid understanding of the drug development process and the principles, concepts, practices, and standards of pharmaceutical project management.
  • Excellent interpersonal, organizational, written and verbal communication skills.
  • In-depth knowledge and skill with Microsoft Project, Microsoft Word, Microsoft Excel, and other reporting and tracking tools.
  • Ability to accommodate shifting priorities, demands and timelines.
  • Ability to learn, understand and apply new technologies, strategies and approaches that enhance the teams ability to achieve goals and meet timelines/deliverables.

Scope:

Manages projects to achieve goals in accordance with established policies, meet schedules and resolve problems; Works on problems that may affect multiple functional areas. Interacts with management on matters concerning functional and cross-functional areas.

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.


PI114674450

<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><strong><u>Position Summary:</u></strong> Provide project support in managing multiple cross functional workstreams in support of sNDA and therapeutic area program deliverables. Responsible for the communication of project status and issues while ensuring corporate goals in collaboration with the program team are met on time.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li><strong><u>Regulatory Submission</u></strong>: Collaborate with PM Lead/ Regulatory Lead in the management of integrated timeline and coordination of cross functional deliverables in support of sNDA submission.</li> <li><strong><u>Timeline Management: </u></strong>Assist with managing project timelines to plan with a clear understanding of functional interdependencies and critical path activities.</li> <li><strong><u>Project Reporting:</u></strong> Lead consolidation of project status reports including dashboards and other metric tools to monitor progress against milestone targets.</li> <li><strong><u>Risk Management:</u></strong> Work closely with PM in developing, monitoring and managing of project related risks as well as providing support in defining and implementation of mitigation and contingency plans.</li> <li><strong><u>Relationships:</u></strong> Develop relationships and interact cross functionally as well as with all levels of management</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>Bachelors degree in life sciences and/or combination of education/experience</li> <li>Minimum 8-10 years of progressively responsible, relevant experience focusing on project management which includes experience managing cross-functional project teams.</li> </ul> <p><strong>Must possess</strong><strong>:</strong></p> <ul> <li>Ability to support multiple project teams simultaneously, be well organized and have strong time management skills and attention to detail.</li> <li>Experience supporting regulatory submissions i.e., IND, NDA, sNDA and BLA</li> <li>Familiarity with FDA and/or EMA Regulations, ICH Guidelines, and GXPs governing the conduct of clinical trials is required.</li> <li>A solid understanding of the drug development process and the principles, concepts, practices, and standards of pharmaceutical project management.</li> <li>Excellent interpersonal, organizational, written and verbal communication skills.</li> <li>In-depth knowledge and skill with Microsoft Project, Microsoft Word, Microsoft Excel, and other reporting and tracking tools.</li> <li>Ability to accommodate shifting priorities, demands and timelines.</li> <li>Ability to learn, understand and apply new technologies, strategies and approaches that enhance the teams ability to achieve goals and meet timelines/deliverables.</li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Manages projects to achieve goals in accordance with established policies, meet schedules and resolve problems; Works on problems that may affect multiple functional areas. Interacts with management on matters concerning functional and cross-functional areas.</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> </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/1wpPYbtGKLJ8uAprUM8Vx"> <p>PI114674450</p>

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Posted: 2019-10-18 Expires: 2019-11-18

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Temporary Associate Director, Clinical Project Management

ACADIA Pharmaceuticals
Princeton, NJ 08540

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