Director Translational Sciences – Nonclinical Pharmacokinetics
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
This role will be responsible for Pre-Clinical DMPK deliverables across all of the therapeutic areas at ACADIA with a clear understanding of functional interdependencies and critical path activities! The director of DMPK is an integral member of the project teams, represents the department and provides subject matter expertise, assists in developing and applying DMPK strategies from discovery stage programs to early development (pre-IND) through NDA filings of diverse drug products in development. In addition to these responsibilities, the ideal candidate will also supply scientific and technical input to the design of Phase I protocols, prediction of first-in-human pharmacokinetics, and help coordinate and implement the clinical pharmacokinetic elements of the Phase I studies. Another key role is to oversee bioanalytical activities related to the assessment of drug exposures and metabolism, from development to regulatory submission!
- Effectively representing the department in cross-functional teams to ensure integration of modern pharmacokinetic principles in supporting preclinical discovery stage/lead-optimization, IND-track, and clinical-stage programs
- Perform pharmacokinetic non-compartmental and compartmental analyses and provide sound interpretation of the pharmacokinetic results
- Assimilate pharmacological, pharmacodynamic, and toxicokinetic data to model and predict therapeutic human dose and safety margins
- Provide pharmacokinetic input and work cross-functionally with study biostatisticians, medical writers, clinical trial managers, and representatives from Regulatory Affairs, in support of phase I and proof of concept trials
- Responsible for the preclinical pharmacokinetic-related section in documents, including study reports; DMPK components of investigator brochures, and regulatory documents
- Interact with members from various subject areas; serves as a pharmacokinetic SME and collaborates closely with partners on projects
- Ensures an adequate follow-up of studies and project timelines.
- Facilitate the establishment of contracts with CROs selected to perform bioanalytical analyses and handle budget, agreements, and timelines
- Lead bioanalytical activities for multiple studies across several programs and therapeutic areas
- Lead all aspects of assay development, validation, generation, and completion of assay performance reports
- Act as a subject matter expert at bioanalytical compliance and regulatory audits
- Ph. D. from an accredited college or university in pharmacokinetics or pharmacology with a strong pharmacokinetics background, clinical pharmacology, pharmaceutics, clinical pharmacokinetics or bio-pharmaceutics
- Desired experience in a closely related field and a minimum of 5-10 years experience in the Pharmaceutical Industry working in DMPK, bio-analysis, and drug metabolism.
- Strong foundation in pharmacokinetics and a detailed understanding of non-clinical and clinical DMPK processes
- Demonstrated ability to successfully lead the pharmacokinetic components of multiple drug product candidates in early phases of discovery and development
- An understanding of regulatory documentation requirements for IND and NDA submissions, including experience handling pharmacokinetic aspects of regulatory agency interactions
- Sound working knowledge of the cross-functional interfaces that are important for efficient drug development
- Expertise in Clinical Pharmacology, PK/PD, and Population PK modeling is also desirable
- Ability to present sophisticated issues in oral and written form
- Ability to work independently, take initiative, and complete tasks to deadlines
- Requires attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
- Ability to effectively present information to management, external contractors, and employees at all levels of the organization
Serve as DMPK and bioanalytical lead and drive the execution and implementation of all related activities from protocol concept to final report including interpretation of pharmacokinetic results. Create and maintain internal and external networks to preserve ground breaking knowledge in pharmacokinetic and bioanalytical approaches. Represent and lead preclinical pharmacokinetic and bioanalytical contributions to all regulatory documents. Maintain extensive scientific awareness that allows continuous improvement and resolution of emerging issues during drug development.
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. The employee must occasionally lifts and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.
What we offer you:
- 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
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 [email protected] 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.