Director, Drug Metabolism and Pharmacokinetics
Responsible for Preclinical and Clinical ADME (absorption, distribution, metabolism, excretion) and Pharmacokinetic results across all therapeutic areas. The Director is an integral member of the project teams, represents the department, provides subject matter expertise, and strategically leads the application of scientific and regulatory ADME, DDI, and Pharmacokinetic principles for the development of various drug products from preclinical candidate selection (pre-IND) through NDA filings and post-marketing commitments. This role is expected to provide their scientific and technical expertise to design ADME/Pharmacokinetic studies, which includes protocol development, monitoring of external study activities, data review, interpretation and quality control, finalization of reports, and communication of study results. This role will also author bioanalytical content related to drug assay in regulatory submissions and respond to regulatory questions on bioanalytical and ADME/Pharmacokinetic data and interpretation.
- Effectively representing the department in cross-functional teams to ensure the integration of modern pharmacokinetic principles in designing the toxicokinetic and clinical pharmacokinetic plans
- Perform pharmacokinetic non-compartmental and compartmental analyses and provide interpretation of the pharmacokinetic results for toxicokinetics and Phase 1 studies
- Bridging toxicokinetic findings and prediction of human pharmacokinetics by applying appropriate approaches, such as allometric scaling
- Provide pharmacokinetic input and work collaboratively with study biostatisticians, medical writers, clinical trial managers, and representatives from Regulatory Affairs, in support of the phase I and proof of concept trials
- Responsible for the preclinical and clinical pharmacokinetic-related section in documents, clinical protocols, study reports, investigator brochures, and regulatory documents
- Interacts effectively with members from various fields; serves as pharmacokinetic authority and liaises with partners on projects
- Ensures follow-up of studies and project timelines.
- Facilitate establishment of contracts with CRO’s selected to perform bioanalytical analyses and handle budget, agreements, and timelines
- Lead bioanalytical activities for studies across several programs and therapeutic areas
- Supervise assay development, validation, generation, and completion of assay performance reports
- Coordinate input into clinical study documents such as the protocol, lab manual, CRFs, and data and bioanalytical report deliverable timelines
- Act as a subject matter expert in bioanalytical compliance and regulatory audits
- Other duties as assigned.
Education and Experience
- MD, PhD, or PharmD in pharmacokinetics, pharmaceutics, biopharmaceuticals, or a related field.
- Targeting 10 years’ experience in the Pharmaceutical Industry working in pharmacokinetics, bioanalysis, and drug metabolism.
- An equivalent combination of related education and experience may be considered.
- Demonstrated ability to successfully manage the drug metabolism, preclinical and clinical pharmacokinetic components of multiple drug products in early phases of development
- Demonstrated modern knowledge of international regulatory guidance pertaining to bioanalysis and ADME/Pharmacokinetics topics
- Demonstrated ability to successfully lead pharmacokinetic aspects of regulatory agency interactions
- Demonstrated ability to successfully interact with internal staff and manage external bioanalytical vendors
- Strong foundation in preclinical and clinical pharmacokinetics and a detailed understanding of non-clinical and clinical DMPK processes
- A sound working knowledge of regulatory documentation requirements
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
- Excellent interpersonal, communication, analytical, and organizational skills
- Ability to effectively present information to management, external contractors, and employees at all levels of the organization
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 independently, overnight, and after hours if required by travel schedule or business issues.
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 firstname.lastname@example.org 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 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.