- Develop, contribute to, and oversee the execution of the signal detection strategy for the Arcus portfolio.
- Coordinate cross-functional Safety Review Teams and Safety Management Committees.
- Preparation and review of periodic aggregate reports (IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), EU renewal, etc.)
- Review, contribute, and author as appropriate, relevant sections of the clinical trial protocols, the Investigator's Brochure (IB), Company Core Data Sheet (CCDS), informed consent form (ICF) and other study specific documents to ensure alignment with the asset benefit-risk profiles.
- Collaborate with business partners and contribute to the investigational products NDA and BLA submission.
- Medical review of selected individual case safety reports (ICSRs).
- Leads the effort to create developmental risk management plans by seeking input from cross-functional stakeholders.
- Provides strategic medical input into Regulatory Authority safety assessments and requests for information.
- Prepare and review relevant sections of the Regulatory Authority filing and submission packets for Investigational New Drug (IND), New Drug Applications (NDAs), Marketing Authorization Applications, etc.
- Participate in and provide input for Drug Monitoring Committees (DMC), as applicable.
- Contribute to scientific publications (abstracts, posters, papers) for scientific meetings and/or journals.
- Contribute, as appropriate, to the medical safety evaluation of projects for new business development opportunities (e.g., due diligence evaluations).
- Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) degree required. Academic or hospital setting experience preferred.
- 3+ years relevant Safety Physician experience required. Working in oncology with NDA and BLA submissions experience preferred.
- Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within the Safety department.
- Demonstrated ability to work effectively in a dynamic, complex, cross-functional, and fast-paced team environment.
- Excellent interpersonal, communication, analytical, and organizational skills.
-
Patient Safety Specialist
1 week ago
UCSF Benioff Children's Hospital Oakland Oakland, United States**Job Description/Summary**: · Under the direction of the Patient Safety Manager, the Patient Safety Specialist will participate in the promotion of a culture of quality and safety throughout the organization. The Patient Safety Specialist is committed to continuously improving p ...
-
Medical Director, Patient Safety
2 weeks ago
Arcus Biosciences Hayward, United StatesThe Medical Director, Patient Safety and Pharmacovigilance will provide medical expertise across the growing Arcus clinical portfolio by supporting a variety of core medical safety activities including the management of safety signal, risk management, benefit-risk strategies, and ...
-
Senior Medical Director, Patient Safety
1 week ago
Arcus Biosciences, Inc. Brisbane, United StatesThe Senior Medical Director, Patient Safety & Pharmacovigilance will provide medical expertise and leadership across the growing Arcus oncology clinical portfolio by supporting a variety of core medical activities including the management of safety signal, risk management, and be ...
-
Director of Patient Safety
1 week ago
University of California, San Francisco SanFrancisco, United States· Patient Safety · Full Time · 75501BR · Job Summary · The Director of Patient Safety provides leadership and direction in design, development, implementation, and evaluation of a comprehensive Patient Safety Program, ensuring compliance with existing regulations, standards, and ...
-
patient safety specialist
3 weeks ago
Children's Hospital & Research Center Oakland, CA , USA, United StatesJob Description/Summary: Under the direction of the Patient Safety Manager, the Patient Safety Specialist will participate in the promotion of a culture of quality and safety throughout the organization. #The Patient Safety Specialist is committed to continuously improving patien ...
-
patient safety specialist
3 weeks ago
UCSF Benioff Children's Hospital Oakland Oakland, CA , USA, United StatesJob Description/Summary: · Under the direction of the Patient Safety Manager, the Patient Safety Specialist will participate in the promotion of a culture of quality and safety throughout the organization. The Patient Safety Specialist is committed to continuously improving patie ...
-
Manager of Patient Safety
3 weeks ago
CommonSpirit Health Redwood City, United StatesOverview: · About Sequoia Hospital Hello Humankindness · Dignity Health Sequoia Hospital is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. Sequoias Heart and Vascular Institute is a nation ...
-
Manager of Patient Safety
3 weeks ago
CommonSpirit Health Redwood City, United StatesOverview · About Sequoia Hospital - Hello Humankindness · Dignity Health Sequoia Hospital is an accredited, not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. Sequoia's Heart and Vascular Institute is a nati ...
-
Director - Patient Safety
2 days ago
Stanford Health Care Palo Alto, United States Paid WorkIf you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. · Day - 08 Hour (United States of America) · This is a Stanford Health Care job. · A Brief Overvie ...
-
Psychological Asst
2 weeks ago
Kaiser Brisbane, United States Full timeJob Summary: · Under the supervision of a licensed Psychologist or board certified Psychiatrist, provides mental health assessment, diagnosis, treatment and crisis intervention services for adult and/or child members who present themselves for psychiatric evaluation with a broad ...
-
Medical Director, Patient Safety
1 week ago
Arcus Biosciences, Inc. Hayward, United StatesThe Medical Director, Patient Safety and Pharmacovigilance will provide medical expertise across the growing Arcus clinical portfolio by supporting a variety of core medical safety activities including the management of safety signal, risk management, benefit-risk strategies, and ...
-
Clinical Trial Manager
1 week ago
Vera Therapeutics Brisbane, United States**Title: Clinical Trial Manager** · **Location**:Brisbane, CA** · **About Us**: · Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate ...
-
CRNA - S San Francisco - Full-time
2 weeks ago
Kaiser South San Francisco, United States Full time$53,000 + sign-on bonus eligible · Job Summary: · Selects and administers intravenous, spinal and other anesthetics prior to and during surgical or medical procedures, as a member of the anesthesia care team and in accordance with Kaiser Permanente policies and procedures. Monito ...
-
Staff Nurse II
3 days ago
Kaiser South San Francisco, United States Full time· An All-Inclusive Opportunity · To optimize your experience applying to a job at Kaiser Permanente we have created a unique and easy all-inclusive process to apply for all open career opportunities in this specific nursing specialty for this Medical Center relevant to your work ...
-
Staff Nurse II
5 days ago
Kaiser South San Francisco, United States Full timeJob Summary: · The Registered Nurse (RN) II is a professional caregiver who assumes responsibility and accountability for a group of patients for a designated time frame. The RN II provides care to patients via the therapeutic use of self, the nursing process, the environment and ...
-
Assistant Nurse Manager, ICU
2 weeks ago
Kaiser South San Francisco, United States Full time"External Candidates Eligible for Sign On Bonus" · Job Summary: · Manages activities of the unit(s), monitors quality, service and utilization standards. Supervises the day to day shift activities. · Essential Responsibilities:Manages the units day to day clinical operations incl ...
-
Abdera Therapeutics South San Francisco, United States**Who we are** · Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies · - one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform opt ...
-
Research Associate I
1 week ago
Cytokinetics South San Francisco, United States**Responsibilities** · - Accomplish the synthesis of enough designed target molecules and key intermediates with high productivity for biological, DMPK and in vivo studies. · - Summarize/interpret data and present findings in research meetings. · - Maintain detailed experimental ...
-
Software Project Manager
5 days ago
Thermo Fisher Scientific South San Francisco, United StatesThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisti ...
-
Quality Patient Safety Program Manager
1 week ago
CommonSpirit Health Redwood City, United StatesOverview: · About Sequoia Hospital Hello HumankindnessDignity Health Sequoia Hospital is an accredited not-for-profit community hospital providing innovative and exceptional health care for generations of Bay Area residents. Sequoias Heart and Vascular Institute is a nationally ...
Medical Director, Patient Safety - Brisbane, United States - Arcus Biosciences
Description
The Medical Director, Patient Safety and Pharmacovigilance will provide medical expertise across the growing Arcus clinical portfolio by supporting a variety of core medical safety activities including the management of safety signal, risk management, benefit-risk strategies, and marketing submissions for the assets as well as medical review of selected individual case safety reports (ICSRs). This individual must effectively collaborate cross-functionally at all levels of the organization as well as with external Regulatory Authorities. This leader will report into the Sr. Medical Director for Patient Safety and Pharmacovigilance.
Responsibilities
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
#LI-EW1
#LI-Remote
