Executive Director Translational Medicine
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
Acadia is seeking an accomplished neuroscience research and development expert with leadership experience in translational medicine and early-stage clinical drug development strategy and tactics.This role is accountable for, or a key contributor to, the strategic planning, design, and execution of clinical studies from first in human to Proof of Concept (PoC) that demonstrate target engagement, proof-of-mechanism and pharmacodynamic response to treatment, characterize biomarker-driven PK/PD relationships, and explore early signs of efficacy and patient stratification metrics. Responsibilities include the management of the Clinical Pharmacology function as well as the assessment of licensing opportunities and assessment of their compatibility with the existing portfolio. The role involves drug development across multiple disease areas in neuroscience and will oversee the global early development programs, design and execution of phase I studies and support of late phase development (Phases III-IV), leading clinical pharmacology aspects if IND, NDA/MAA/NDS submissions and advisory boards.
- Establish strategic plans for designated function(s) and participate with senior management to align objectives across the organization.
- Develop early clinical development plans including study designs, and associated protocols t for all phase I studies
- Design, plan and implement biomarker strategies to inform indication priorities, commercial differentiation, target engagement, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs
- Coordinate statistical analysis plan and TLFs for Phase I studies
- Direct and supervise the preparation and review of protocols, clinical study reports, clinical pharmacology and translational medicine sections of early development plans, IBs, INDs, BLAs, SOPs, abstracts, manuscripts, and technical reports
- Provide of appropriate clinical pharmacology sections and reviewing protocols and reports for Phase II-IV studies as needed.
- Design, development and interpretation of models for target engagement, proof principle, proof of mechanism and PK/PD as appropriate
- Provide medical oversight for all phase I studies
- Develop methods, techniques, and evaluation criteria for projects and programs.
- Ensure compliance with appropriate SOP’s GCP and ICH guidelines for all Clinical Pharmacology-related studies.
- Acquire and maintain knowledge of national and international guidelines.
- MD highly preferred. An equivalent combination of relevant education and applicable job experience may be considered. Additional degree in basic sciences is a plus (MSc, PhD)
- Minimum of 15 years of progressively responsible experience in Clinical Pharmacology, Experimental Medicine and Translational Research in Central Nervous System disorders including a minimum of 10 years in a leadership role
- Experience in the design and conduct of Phase I studies
- In-depth knowledge of Clinical Pharmacology-related submissions (IND, NDA/MAA/NDS)
- Excellent interpersonal communication and networking skills with the ability to build cross functional bridges
- Strong analytical and problem-solving skills. Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals
- Employee must be fully vaccinated against Covid-19 in accordance with our policy
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. Employee must occasionally lift and/or move up to 15 pounds.
Employee must be fully vaccinated against Covid-19 in accordance with our policy and in order to meet any independent vaccination requirements that our clients and client facilities may have.
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.