Associate Director, Clinical Data Management
$136k - $170k USD
About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
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
The Associate Director will collaborate with the Clinical Data Management team by providing leadership and knowledge. Assists the head of Data Management in directing the design, documentation, testing and implementation of clinical data collection studies, and clinical database reviews in support of company objectives. Ensures that the data management systems are business ready and of appropriate quality to fulfill those objectives. Focuses on the oversight of quality data deliverables within Acadia Data Management and projects with Contract Research Organizations (CROs).
Primary Responsibilities
- Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems.
- Assists in identifying and resolving data management issues on assigned studies.
- Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced.
- Provides strategic input into protocol design focused on data management portions.
- May assist Biostatistics in development/review of Statistical Analysis Plans.
- Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable.
- Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorisation Application (MAA), including integrated databases.
- Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities.
- Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality.
- Oversees projects that have been engaged with CROs, as well leads and manages internal projects.
- Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies.
- Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions.
- Assures compliance with industry quality standards, guidelines and procedures.
- Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function.
- May sssist in the career development of Data Management personnel. Position may have direct reports.May assist with input into corporate and department budget process and management.
- Other responsibilities as assigned.
Education and Experience
- Bachelor’s degree in Life Sciences, Mathematics or related field. Targeting 8 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry. An equivalent combination of relevant education and experience may be considered.
- Previous experience in data management from protocol concept through database lock and clinical study report finalization.
- Knowledge of medical terminology.
- Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency in MS Office applications.
- Proficiency with data management systems and supporting statistical programs (e.g., SAS),
- Knowledge of database design and database concepts.
- Skilled at cross-functional/department communications to gain cooperation of others.
- Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals.
- Able to make and prioritize process and resource decisions based on overall team needs.
- Must be able and willing to travel on occasion.
Physical Requirements
This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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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
$136,200—$170,300 USD
What we offer US-based Employees:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 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
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- 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 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 strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe 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 accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
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