Acadia Pharmaceuticals
Associate Director Clinical Trial Materials
Acadia Pharmaceuticals, San Diego, California, United States, 92101
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Job Detail
October 29th, 2024
Pharmaceutical Development
Associate Director, Clinical Trial Materials
San Diego, California, United States
View All Jobs
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinsons disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimers disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at
Acadia.com
and follow us on
LinkedIn
and
X
.
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary:
In support of clinical development programs, the Associate Director of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.
Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required.
Primary Responsibilities:
Review and Interpretation of a clinical protocol or study overview:
Review and provide feedback during the development of the clinical protocol.
Calculate total demand and translation of total demand into a demand forecast.
Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
Tracks expired materials and issues orders for retrieval or disposal.
Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
Proposes and implements improvements to assure efficient clinical supply operations.
Investigates and resolves issues regarding inventory, shipments and returns.
Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
Reconciles and approves invoices
Prepares reports to ensure accuracy and completeness of clinical supplies information.
Maintains departmental reports and files, updates SOPs and other projects as assigned
Education/Experience/Skills
Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree).
Equivalent combination of relevant education and applicable job experience may be considered with at least 8 years experience in pharmaceutical development focused on clinical trial materials
The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
Proven project management skills
Ability to handle multiple projects simultaneously
Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
Good understanding of IRT system build-up and user testing
Good negotiating skills with customers and suppliers
Hands on training and experience in clinical trial methodology and Good Clinical Practice
Good organizational and documentation skills
Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
Excellent written and verbal communication skills
Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
Skilled at creating a cooperative team environment
Able to objectively evaluate situations and make recommendations for changes in light of overall project demands
Scope:
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Determines methods and procedures on new assignments and may coordinate activities of other personnel.
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 20% of the time and work after hours if required by travel schedule or business issues.
#LI-hybrid
#LI-RT
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
Salary Range
$140,000
$175,000 USD
What we offer you (US-Based Employees):
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave
Tuition assistance
EEO Statement (US-Based Employees):
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply
especially if the reason you are the best candidate isnt exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadias career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our
Reasonable Accommodation Request Form
or contact us at
talentacquisition@acadia-pharm.com
or
858-261-2923
.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants:
Please
see our
California Applicant Privacy Notice
within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters):
The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (Acadia). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
Acadia Careers
Acadia Job Listings
Job Detail
October 29th, 2024
Pharmaceutical Development
Associate Director, Clinical Trial Materials
San Diego, California, United States
View All Jobs
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinsons disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimers disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at
Acadia.com
and follow us on
and
X
.
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary:
In support of clinical development programs, the Associate Director of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.
Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required.
Primary Responsibilities:
Review and Interpretation of a clinical protocol or study overview:
Review and provide feedback during the development of the clinical protocol.
Calculate total demand and translation of total demand into a demand forecast.
Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
Tracks expired materials and issues orders for retrieval or disposal.
Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
Proposes and implements improvements to assure efficient clinical supply operations.
Investigates and resolves issues regarding inventory, shipments and returns.
Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
Reconciles and approves invoices
Prepares reports to ensure accuracy and completeness of clinical supplies information.
Maintains departmental reports and files, updates SOPs and other projects as assigned
Education/Experience/Skills
Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree).
Equivalent combination of relevant education and applicable job experience may be considered with at least 8 years experience in pharmaceutical development focused on clinical trial materials
The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
Proven project management skills
Ability to handle multiple projects simultaneously
Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
Good understanding of IRT system build-up and user testing
Good negotiating skills with customers and suppliers
Hands on training and experience in clinical trial methodology and Good Clinical Practice
Good organizational and documentation skills
Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
Excellent written and verbal communication skills
Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
Skilled at creating a cooperative team environment
Able to objectively evaluate situations and make recommendations for changes in light of overall project demands
Scope:
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Determines methods and procedures on new assignments and may coordinate activities of other personnel.
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 20% of the time and work after hours if required by travel schedule or business issues.
#LI-hybrid
#LI-RT
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
Salary Range
$140,000
$175,000 USD
What we offer you (US-Based Employees):
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave
Tuition assistance
EEO Statement (US-Based Employees):
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply
especially if the reason you are the best candidate isnt exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadias career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our
Reasonable Accommodation Request Form
or contact us at
talentacquisition@acadia-pharm.com
or
858-261-2923
.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants:
Please
see our
California Applicant Privacy Notice
within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters):
The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (Acadia). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.