Senior Director, Clinical Trials Materials Management

Industry:

Company: Acadia Pharmaceuticals Inc.

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 Parkinson’s 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, Alzheimer’s 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 on average in our office three days per week.

Responsible for oversight of Clinical Trial Material (CTM) / Investigational Medicinal Materials (IMP) planning and execution activities, supporting Phase 1-IV and IIS trials. Leads a team of Clinical Supply Managers who ensure uninterrupted availability of CTMs/IMPs. Runs a CTM/IMP group vision to ensure the CTM/IMP team is well positioned to support existing and sustained growth to support clinical studies in US and outside US. Develops and continuously assesses the clinical supply chain strategy that considers regulatory landscape, vendor capabilities, internal and external resource availability, evolution of technologies, and industry trends. Acts as the functional owner for the CTM group and is recognized as the subject matter authority for Clinical Supply Chain Management. strategic multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical development results related to drug product development in reports and certificates of analysis.

Primary Responsibilities:

• Establishes vision and strategic direction for CTM function.
• Develops clinical supply chain resource plan to position the CTM group for future scalability.
• Ensures operational efficiency and compliance of supply chain processes compliance for packaging, labeling, sourcing, and distribution logistics.
• Identifies existing process/capabilities gaps; Prioritizes and sponsors strategic supply chain initiatives to address gaps.
• Establishes department standards and collaborates with cross functional partners to agree on expectations.
• Defines department digital supply chain system needs.
• Provides Leadership to Clinical Trial Material Team
• Ensures CTM team effectively plans and implements in accordance with Study Team timelines.
• Defines expectations of CTM team and holds team accountable.
• Creates career development plans for CTM team members.
• Mentors CTM team
• Leads CTM supply team meetings.
• Align operational execution practices across team members.
• Accountable for department budget
• Defines forward-looking functional team budget and tracks spending against the budget plan.
• Identifies opportunities for cost savings and develops plans for implementation.
• Partners with Finance and Procurement to ensure financial transparency.
• Establishes relationships and collaborates with cross functional leadership including but not limited to Clinical Operations and GMP Quality to align on business timelines and priorities.
• Implements strong Vendor Management oversight model for Clinical Supply Chain Vendors.
• Leads Business Review Meetings.
• Identifies opportunities with vendors and negotiates cost saving incentives.
• Leads escalation of issues to vendor Sr. Management.

Education/Experience/Skills:

For Senior Director: A minimum of a BS/BA in Chemistry, Supply Chain Management, or related field. Master’s degree is preferred. An equivalent combination of relevant education and applicable job experience may be considered. A minimum of 12 years of clinical supply management experience demonstrating a dynamically increasing scope of responsibility. A minimum of 5 years in a clinical supply leadership role with US and international clinical trial experience is required. Must be an expert in GXP requirements and is knowledgeable of industry services providers, trends, and challenges. A strong understanding of regulatory requirements impacting the clinical supply chain is required.

• Strong understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH guidance, 21 CFR Part 211, 21 CFR Part 11).
• Working knowledge of United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP), British (BP) and other established pharmacopoeias.
• Strong understanding of EU and EC CTR regulations.
• Demonstrated problem solving abilities.
• Strong organizational and documentation skills.
• Demonstrated verbal and written communication skills.
• Ability to lead and manage change in a dynamic environment.
• Expert understanding of clinical supply chain functional interdependencies.
• Skilled at negotiating with business partners, stakeholders, service providers.
• Proficient in the ability to influence and inform senior level leaders regarding matters of significance to the department.
• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.
• Ability to travel up to 30% of the time both domestically and internationally.

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, airplane or train independently up to 30% of the time and work after hours if required by travel schedule or business issues.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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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

$215,000-$268,200 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 isn’t 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 Acadia’s 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.