Associate Director, Early Stage Drug Product Development

Location: Princeton, NJ and San Diego, CA. Position Summary The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues. The role will be critical in ensuring that we select, develop, and accelerate the introduction of new chemical entities into the Acadia pipeline. Primary Responsibilities Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products. Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers. Initiate and manage supplier contract agreements as necessary. Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs. Serves as person-in-the-plant at the CSP sites. Plans project‑related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports. With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates. Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on‑site preparations. Conduct physicochemical characterizations of the new drug candidates to support developability assessments. Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs. Liaises with the CMC team, late‑stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates. Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD). Other responsibilities as assigned. Education, Experience, and Skills Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered. A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired. Demonstrated success in the field of formulations and dosage form development. Experience authoring technical reports and CMC sections for regulatory filings. Must possess: Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development. Extensive knowledge of cGMPs. Skilled at managing CSPs. Demonstrated verbal and written communication skills. Adept at effectively aligning resources across multiple functional areas to achieve functional area goals. Flexibility to travel 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 to domestic and international locations is required. Salary Range $154,000—$192,700 USD Benefits 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 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 View email address on click.appcast.io or View phone number on click.appcast.io. #J-18808-Ljbffr