Associate Director, Non-clinical Drug Safety
$169.22k - $253kOtsuka Pharmaceutical Co., Ltd
- # Associate Director, Non-clinical Drug SafetyApply: Remote: Full time: Posted Yesterday: R12651**Job Summary**The Associate Director, Non-clinical Drug Safety is responsible for technical and scientific matters related to the design, execution and evaluation of non-clinical safety and toxicology for small molecules and biologics. The role independently leads nonclinical safety strategies for assigned development programs and provides expert scientific guidance to cross-functional teams to support program advancement and regulatory objectives. This includes the preparation of regulatory documents such as INDs, NDAs/BLAs, aggregate reports, fast track designation, 8-FA, ICFs, and briefing books. **Job Description*** Serve as the toxicology subject matter expert on cross-functional discovery and development teams and provide strategic nonclinical safety recommendations to support program progression and development decision-making* Lead and oversee IND and NDA enabling GLP toxicology studies* Review, analyze and interpret scientific data and results for toxicology studies and integrate findings into overall nonclinical safety assessments and development strategies* Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs* Communicate toxicology findings and risk assessments to project teams and senior leadership, influencing program decisions through scientifically sound and risk-based recommendations* Act as author/co-author and reviewer of regulatory documents* Collaborate within the nonclinical team to incorporate new guidance requirements* Analyze competitive scientific knowledge from external sources* Contribute to continuous improvement initiatives, scientific standards, and implementation of evolving regulatory guidance within Nonclinical Drug Safety **Qualifications/ Required*** MSc or PhD in Toxicology, Pharmacology or related areas with at least 7 years of experience in a pharmaceutical company or contract research organization* Diplomate of the American Board of Toxicology (DABT) is highly desired.* Strong preference to experience in Biologics* Strong technical experience in planning and executing nonclinical studies* Thorough knowledge of regulatory requirements and the overall drug development process* Regulatory expertise preferred, including successful IND/CTA submissions* Ability to switch tasks and priorities as business needs change and manage multiple programs simultaneouslyDetail-oriented with strong written and verbal communication skills**Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative.Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
- J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Non-clinical Drug Safety in Brooklyn, NY vacancy
$158k - $197.9k
Position Summary The Associate Director is a hands-on technical... ...responsible for automating how clinical data are integrated... ...eCOA and IRT vendors, safety systems, and other... ..., and AI use in drug development, and recommends... ...to technical and non-technical stakeholders...SuggestedWork at officeLocal areaRemote workNight shift$155k - $259k
## Associate Director - Clinical Operations - HealthcareApplylocations: US - Remote (Any location)time type: Full timeposted on: Posted Todayjob requisition... ...performance improvement, supply chain, workforce and non-labor productivity, clinical operations, shared services,...SuggestedContract workTemporary workWork at officeRemote workFlexible hours- All Jobs > Associate Director or Director, Clinical Outsourcing Associate Director or Director, Clinical Outsourcing Fully Remote Remote - Nationwide Description About BridgeBio Oncology Therapeutics BBOT is a clinical-stage biopharmaceutical company advancing a next...SuggestedContract workRemote work
$169.22k - $253k
**Role Summary**The Associate Director, COA develops and executes the COA strategy for one or more assigned clinical programs, applying qualitative and quantitative methods to support... ...knowledge of FDA/EMA patient focused drug development guidances and their application...SuggestedTemporary workLocal areaFlexible hours- Position Title: Associate Director, Program Management - Clinical, Medical & Regulatory Location: Remote/Philadelphia, PA Reports to: Sr. Director, Program Management Department: Program Management Office Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology...SuggestedRemote work
- Acadia Pharmaceuticals Inc. seeks an Associate Director to automate clinical data integration across compounds and studies, building reusable R and Python dashboards and data review tools on the Posit platform. This hands-on role will design automated ingestion pipelines...
- Description We are seeking a Associate Director, Clinical Operations to provide strategic leadership and... ...Investigator Brochures, Investigational New Drug Applications (INDs) and/or... ...IND and NDA documents, DSURs and other safety reports; may be responsible for the management...
- Job Summary The Associate Director of Pediatric Clinical Research - Cancer Center, serves as the senior operational and execution leader for all pediatric... ...or eligibility) 8-10 years of advanced knowledge of drug development pathways, IND driven research, FDA regulatory...
$186k - $220k
...structure‑based and computational drug discovery technology. The... ...drugs. We are advancing a clinical‑stage pipeline of... ...location. Position Summary: The Associate Director of Clinical Operations plays... ...escalation when necessary. Safety & Compliance Oversight: Work...Remote work$164.61k
Associate Counsel III Senior Director Health Care Legal Services Job Category: Administrative, HR, Business Professionals... ...and residents and to support the safety net required to achieve that purpose... ...matters. This position provides non-supervisory guidance for staff...Full timeFor contractors$256k
...team at NYC Health + Hospitals/Gotham Health, Broadway as Associate Medical Director. Our dedicated team at NYC Health + Hospitals/Gotham... ...spectrum care for both children and adults using the best clinical practices and tools to manage patient health. As part of...Full timeImmediate startFlexible hoursWeekend workAfternoon shiftPhysician Affiliate Group of New York, P.C. (PAGNY)
Brooklyn, NY4 days ago- The Department of Psychiatry at SUNY Downstate Health Sciences University is seeking a full-time Clinical Assistant Professor (HS)/ Associate Clinical Director of Psychiatry at Kingsboro Psychiatric Center.Kingsboro Psychiatric Center is a part of New York State's Office...Full timeTraineeshipWork at office
SUNY Downstate Health Sciences University
Brooklyn, NY3 days ago - ...Associate Clinical Director The Associate Clinical Director assists the Clinical Director in overseeing provision and efficiency of clinical... ...disabilities. Some requirements may be designed to protect the safety and health of the employee, their fellow employees and the...InternshipLocal area
Little Flower Children and Family Services
Brooklyn, NY4 days ago - ...this role:The Technology Research & Innovation AI Governance Associate Director is a senior individual-contributor and thought-leader role responsible... ...skills, with the ability to synthesize complex topics for non-experts, audit, and regulatory audiencesDirect experience...Remote workFlexible hours
DTCC- The Depository Trust & Clearing Corporation
Jersey City, NJ3 days ago $150k - $297k
...comprehensive knowledge in all domains of Information Security and associated technologies in the support of collaboration with partnering... ...unknown interfaces/operating systems/consoles, as well as non-standard devices (i.e. kiosks, IoT devices, mobile phones, etc....Summer holidayLocal areaRemote workFlexible hoursEY (Ernst & Young)
Hoboken, NJ1 day ago- Overview We are seeking a Behavioral Health Associate Medical Director to provide part-time clinical leadership and subject matter expertise in support of the Group Health utilization review program. This contract role provides clinical oversight of behavioral health physician...Contract workPart time
$188.5k - $235.6k
4. Associate Medical Director, Gynecologic Oncology# Associate Medical Director, Gynecologic Oncology## DescriptionAdvance patient care in gynecologic... ...as an Associate Medical Director at Natera. In this clinical leadership role, you will direct medical strategy and...- Bazeta in the United States seeks an Associate Medical Director in Gynecologic Oncology to guide medical strategy for cfDNA and liquid biopsy in... ..., medical affairs and commercial teams to ensure clinical relevance and adoption. The role requires MD/DO with gynecologic...
- Biogen is seeking an Associate Medical Director for Rare Disease in the US to drive medical strategy for SMA and ALS. You will collaborate with Global Medical, Clinical Development and Field Medical to ensure alignment with global strategy and local needs. Responsibilities...Local area
- ...Visalia, CA – Seeking Emergency Medicine Residency Associate Program Director - Partner Join the Physician Partnership Where You Can Increase... ...competency-based curriculum for residents on didactic and clinical education. Supports the Residency Program Director –...Interim roleSummer workSeasonal workLocal area
Vituity
Brooklyn, NY3 days ago - Private Health Management is seeking an Associate Clinical Director focused on Behavioral and Mental Health. Working from a home office, you will lead clinicians, engage with clients, and guide optimized care plans beyond standard care. You’ll collaborate with PHM researchers...Remote jobWork from homeHome office
$120k - $200k
...including establishing control enhancements to reduce errors.Compile the Finance Month-end SOX memo to disclose significant issues and non-routine adjustments discovered during the month-end close.Support internal audit process with the maintenance of SOX controls/...Full timeWork at officeFlexible hoursRoyal Bank of Canada
Jersey City, NJ3 days ago$148k - $173k
...responsibilitiesUBS Business Solutions US LLC is seeking an Associate Director, Engineer in Weehawken, NJ.Are you an innovative thinker? Are... ...completion of critical initiatives and testing engagements. Gather non-functional requirements and identify performance and...Full timeWork at officeRemote workFlexible hoursUBS
Union City, NJ2 days ago$162.6k - $212.6k
## Associate Director, BiostatisticsApply: Remote (US): Full time: Posted Today... ...studies and interact with Clinical,Regulatory, Statistical Programming... ...of experience in clinical drug development is required.... ...salary or hourly range only. Non-Commercial roles are eligible...Hourly payFull timeRemote workBeiGene
Brooklyn, NY4 days ago- FVI School of Nursing and Technology in Miami/Miramar is seeking an Associate Director of Clinical Learning to lead the clinical education across the nursing programs. The role ensures quality, compliance, and effectiveness of learning experiences, including direct patient...
- ...Associate Veterinarian or Medical Director Brooklyn, NY (depending on experience level and leadership abilities) Our client in Brooklyn, NY is a full-service veterinary clinic, equipped with state-of-the-art medical technology and led by an experienced and compassionate...
The VET Recruiter
Brooklyn, NY11 days ago $72k - $75k
...for an accommodation or an alternative application process. Associate Managing Director Full Time Regular Senior Management Boynton Beach, FL, US 2... .... Experience working with influential volunteers or other non-staff stakeholders and managing conflict, change, and competing...Full timeWork at officeLocal areaAfternoon shiftHadassah
Brooklyn, NY3 days ago$72k - $90k
...for an accommodation or an alternative application process. Associate Director, Special Events Full Time Management Brooklyn, NY, US 30+ days... ...Funding & Assessment FLSA Status: Full-time Exempt, Non-Union Grade: 6 Position Description: Reporting to the director...Full timeWork experience placementWork at officeFlexible hoursAfternoon shift- ...technology solutions. About the Role OnePointFive is seeking an Associate Director - Asia Pacific (APAC) Region to lead the delivery and growth... ...growth within the regional practice. Comfortable to work on non-APAC-related projects and initiatives as needed by the...Full timeContract workLocal areaRemote workTrial period
- ...they deserve better Job Summary: The Associate Director, Publications supports the development... ...priorities constructively. Demonstrated clinical and scientific expertise, including experience... ..., executive leadership, and other non-medical audiences, as appropriate....Night shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Non-clinical Drug Safety. Be the first to apply!
Related searches
- retail associate manager Brooklyn, NY
- associate medical director Brooklyn, NY
- associate art director Brooklyn, NY
- associate creative manager Brooklyn, NY
- associate director clinical data management Brooklyn, NY
- associate director marketing Brooklyn, NY
- remote associate product manager Brooklyn, NY
- associate creative director copy Brooklyn, NY
- associate creative director copywriter Brooklyn, NY
- associate director clinical operations Brooklyn, NY