- Under supervision of the Executive Director, Safety Science and as per company policies and procedures, for assigned Denali programs, responsible for safety deliverables for assigned programs or studies.
- Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database.
- Provide safety content for study-level documents including protocols, ICFs, CSR, and when required, to IBs, INDs, CTAs, and NDA/BLA/MAAs
- Coordinating the program level Safety Management Team (SMT) to review safety signal evaluation reports and recommendations for risk characterization.
- Responsible for the completion of safety regulatory submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide
- Track implementation of SMT and DSC decisions.
- May support responses to questions from regulatory authorities.
- Support regulatory agency audits and inspections, and corrective action plans.
- Support PV vendor oversight in collaboration with Safety Operations
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
- Advanced medical degree (e.g., MD, MBBS, DO) required
- 3+ years of experience in the drug safety and pharmacovigilance with a track record of successful deliveries of core safety/PV activities in cross-functional safety teams.
- Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
- Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics.
- Willingness to teach and to learn.
-
Director, Drug Safety Operations
1 week ago
Kaztronix South San Francisco, United StatesA late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a ...
-
Senior Director, Drug Safety
1 week ago
CytomX Therapeutics South San Francisco, United StatesHeadquarters Location: South San Francisco, CA · Candidate Location: Hybrid · Travel Required: 5% · Reports To: Vice President, Clinical Development · Department: Pharmacovigilance · Position Type: Full-time, Exempt · About CytomX Therapeutics: · CytomX Therapeutics, Inc. is comm ...
-
Senior Drug Safety Case Manager
1 week ago
Kaztronix South San Francisco, United StatesA late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a ...
-
Senior Drug Safety Case Manager
3 weeks ago
Cytokinetics, Incorporated South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
-
Medical Director, Global Drug Safety
5 days ago
Denali Therapeutics South San Francisco, United StatesDenali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.The OpportunityIn anticipation of the Company's growth plans, Denali Therapeutics is l ...
-
Associate Director, Drug Safety Operations
1 week ago
Iovance Biotherapeutics Inc San Carlos, United States**Overview** · The Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner companies to achieve department and company goals. · Th ...
-
Senior Manager, Drug Safety
2 weeks ago
BridgeBio Pharma, Inc. San Francisco, United StatesAbout BridgeBio · BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genet ...
-
Director, Drug Safety Operations
1 week ago
Exelixis Inc. Alameda, United StatesSUMMARY/JOB PURPOSE: · This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out. This individual oversees case workload distribution, responds to case questions, coordinates multiple drug safety projects and/ ...
-
Medical Director, Drug Safety
3 days ago
People With Chemistry San Carlos, United States(Sr.) Medical Director, Drug Safety Remote Based Oncology-Hematology | Cell Therapy Pay Range: $280,000 - $340,000 Overview: Meet are exclusively partnering with a mid-sized biotech who have developed a T-cell based immunotherapy platform targeting both solid and liquid tumors. O ...
-
Associate Director, Drug Safety Operations
1 week ago
Iovance Biotherapeutics Inc. San Carlos, United StatesOverview · The Associate Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner companies to achieve department and company goals ...
-
Associate Director, Drug Safety Operations
1 week ago
Iovance Biotherapeutics Inc San Carlos, United StatesJob Description · Job DescriptionSalary: · Overview · The Associate Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner compa ...
-
Associate Director, Drug Safety Operations
2 days ago
Iovance Biotherapeutics, Inc. San Carlos, United StatesJob Description · Job Description Salary: · Overview · The Associate Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner comp ...
-
Associate Director, Drug Safety Operations
1 week ago
Iovance Biotherapeutics, Inc. San Carlos, United StatesJob Description · Job Description Salary: · Overview · The Director of Drug Safety Operations reports to the Head of Drug Safety Operations and will work collaboratively within the Drug Safety department, cross-functionally with other departments, and with partner companies to a ...
-
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 Ii
2 weeks ago
Charles River Laboratories South San Francisco, United States**Req ID #**:222512**Location**:South San Francisco, CA, US, For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health a ...
-
Diesel Mechanic/Technician I
22 hours ago
Penske Truck Leasing South San Francisco, United States Full time62 S. Linden Ave., South San Francisco, CA 94080 · What's the Job? · Ready to move your career forward? As an experienced Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet ...
-
Diesel Mechanic/Technician I
2 weeks ago
Penske Truck Leasing South San Francisco, United States Full time1395 Lowrie St., S. San Francisco, CA 94080 · What's the Job? · Ready to move your career forward? As an experienced Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of ve ...
-
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 ...
-
Service Operations Specialist
2 weeks ago
Tranzeal Inc South San Francisco, United StatesTitle: Services Operations Specialist · Location · - Worksite: Theravance, San Francisco · - CA · Worksite Location: 901 Gateway Blvd, San Francisco, CA, 9408 · **Pay rate** - $22/hr - W2 · **Work Schedule** (Shift/Work Hours):M-F (8 Hours/Day) 7-8AM to 3-5PM · **Job Title**:Serv ...
-
Class C Driver
1 week ago
BiRite Foodservice Distributors Brisbane, United States**CLASS C DRIVER - Pacific Gourmet**Pacific Gourmet is proud to be a part of the BiRite Foodservice Distributors family** · BiRite Foodservice Distributors is a third generation, family-owned company that offers you a Complete Foodservice Solution. We offer unsurpassed service to ...
Medical Director, Global Drug Safety - South San Francisco, United States - Denali Therapeutics
Description
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The OpportunityIn anticipation of the Company's growth plans, Denali Therapeutics is looking for a Medical Director, Global Drug Safety.
This role will work on assigned studies and/or programs therefore responsible for many aspects of safety activities including safety medical review, data analysis and interpretation, preparation of periodic regulatory safety submissions and study reports.
He/she will also contribute to Inspection Readiness and continuous PV process improvement.The successful candidate will have experience in medical and scientific safety assessment in clinical development and preferably also working knowledge of NDA/BLA submissions and continued post-approval safety surveillance.
He/she will be a proven collaborator and self-starter who has the ability to thrive in a matrixed environment.This individual must be able to work in a spirit of collaboration and service, while also operating with an appropriate level of independent judgment.
Denali is seeking candidates with a can-do attitude who work with the highest integrity, fostering an environment of compliance and continuous improvement.
ResponsibilitiesQualifications:
Salary Range:
$265, $291, Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Applicant Privacy Policy
