Executive Director, Global Medical Safety

vor 2 Wochen

Zurich, Schweiz Denali Therapeutics Vollzeit

**Executive Director, Global Medical Safety**

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

**The Opportunity**

**Responsibilities**
- Under supervision of the VP, Head of Drug Safety, and as per company policies and procedures, for assigned Denali programs, has the responsibility and oversight of the risk-benefit strategy and execution
- Responsible for program-level safety strategic planning, implementation, and management of drug safety activities to support clinical development through optimized benefit-risk for patients.
- Responsible for leading the program level Safety Management Team(s) to develop and execute plans pertaining to safety signal management, safety surveillance and risk. Responsible for risk characterization and internal/external safety communication for the molecule. Provide expert safety review and safety content for critical development program documents including protocols, ICFs, IBs, IMPDs, CSRs, INDs, CTAs, and NDA/BLA/MAAs
- Provides medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database
- Responsible for responding to and resolving safety questions from regulatory authorities.
- Responsible for the production of regulatory periodic safety submissions such as development safety update report (DSUR) and other aggregate safety reports for regulatory agencies worldwide
- Collaborates for consistency in safety approaches within drug safety group and with cross-functional colleagues, e.g. medical monitors, toxicologist and pharmacologist
- Support regulatory agency audits and inspections, and corrective action plans
- Support overall growth and operations of Denali and the Drug Safety department. Lead initiatives in developing safety processes and and continuous pharmacovigilance (PV) process improvement. Support PV vendor oversight in collaboration with Safety Operations

**Minimum Qualifications**:

- Advanced medical degree (e.g., MD, MBBS, DO) required
- 7+ years of experience in the pharmaceutical industry. A minimum of 3 years leading cross-functional safety teams in the clinical trial and post
- marketing environments.
- 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
- Demonstrates excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications

LI-SC1

  • Global Medical Director

    vor 1 Woche

    Zurich, Schweiz Novo Nordisk Vollzeit

    Are you looking for an exciting and leading role in supporting Novo Nordisk Rare Disease by extending our commitment and leadership in rare endocrine disorders? Are you looking to work in a fast-paced dynamic and international environment where you can drive change and improve patient care on a larger scale? If yes, then we have the perfect opportunity for...

  • Global Medical Director

    vor 3 Wochen

    Zurich, Schweiz Novo Nordisk Vollzeit

    Are you ready to make the next step in your professional development in a global, expanding company? Are you a strong scientific, innovative thinker with excellent communication, with the ability to work internationally? Do you describe yourself as a talented medical leader within the pharmaceutical industry? Do you enjoy working in a fast growing, dynamic...

  • Oncology, Global Director Medical Affairs Melanoma

    vor 2 Wochen

    Zurich, Schweiz MSD Vollzeit

    The Global Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs Plans for their assigned asset(s). The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. The GDMA contributes to Life Cycle Management...

  • Clinical Director

    vor 1 Woche

    Zurich, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Medical Information Manager

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Job Description **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. **For our Swiss HQ in Zurich, we are looking for a Medical Information Manager /...

  • Associate Director/ Director, Regulatory Affairs:

    vor 1 Woche

    Zurich, Schweiz Novavax, Inc. Vollzeit

    If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases,...

  • Director, Global Pricing

    vor 3 Wochen

    Zurich, Schweiz MSD Vollzeit

    Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. The Director, Global Pricing within the Global Market Access...

  • Medical Information Manager

    vor 2 Wochen

    Zurich, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a Medical Information Manager to join a brilliant pharmaceutical establishment on a contract basis located in Zurich. Our client is focused on providing people internationally with better health and futures. Please note that to be considered for this role you must have the right to work in this location. **Key...

  • Executive Campaign Director in

    vor 2 Wochen

    Zurich, Schweiz Wirz Communications AG Vollzeit

    **Für unser Team suchen wir nach Vereinbarung eine*n Executive Campaign Director*in (80-100%)**: Du bist ein engagierter und kommunikativer Typ, denkst gleichermassen strategisch wie kreativ und heckst gerne den perfekten Plan aus? Du hast ein Faible für analytisches Denken und verstehst es gleichzeitig andere mit deiner begeisternden Art anzustecken? Du...

  • Associate Director, Global Regulatory Strategic

    vor 3 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as a **Associate Director, Global Regulatory Strategic Sourcing** in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVES** - Providing support and assisting the Head of Global...

  • Director of Medical Communications Strategy

    vor 3 Wochen

    Zurich, Schweiz Medicalwriters.com Vollzeit

    Director of Medical Communications Strategy **Job Description**: We are a fast-growing medical communications agency with offices in Zurich, Switzerland and New York, NY. Our team of experienced medical communications professionals help our clients in the pharmaceutical and biotech industry devise and implement transformative medical communications...

  • Associate Director Regional Geime

    vor 2 Wochen

    Zurich, Schweiz MSD Vollzeit

    Regional Expert Input and Medical Education, drives the strategy for Expert Input and Medical Education for the region within a given Therapeutic Area and serves as a key professional interface with global and regional internal stakeholders, scientific leaders, healthcare professionals, and scientific/medical societies. The GEI & MedEd team mission is to...

  • Regional Director Medical Affairs

    vor 1 Woche

    Zurich, Schweiz MSD Vollzeit

    **Job Description**: The** Regional Director Medical Affairs (RDMA)** is responsible for driving execution of scientific & medical affairs plans for Oncology in the countries of their assigned region EUCAN (EMEAC). They are impactful members of regional cross-functional teams, including regional Commercial, Center of Real-World Evidence (CORE), Policy and...

  • Construction Safety Manager Zurich, Switzerland

    vor 2 Wochen

    Zurich, Schweiz Haztek Inc. Vollzeit

    Overview: **Construction Safety Manager** **Zurich, Switzerland** **Bilingual | Fluent German & English** **Must be eligible to work in Switzerland without sponsorship** **HazTek Safety Management** is the largest and most diverse team of full-time construction safety experts in North America. The Company is known for our professional consulting services...

  • Regional Director Medical Affairs, Oncology

    vor 2 Wochen

    Zurich, Schweiz MSD Vollzeit

    **Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 130-year legacy. Our success is backed by...

  • Regional Director for Medical Affairs

    vor 1 Woche

    Zurich, Schweiz MSD Vollzeit

    Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is understood. We connect, communicate and train internal employees to ensure a thorough understanding of the science behind the medicine and review further unmet medical needs to...

  • Director of Marketing

    vor 1 Woche

    Zurich, Schweiz Alchemy Global Talent Solutions Vollzeit

    Alchemy Global Talent Solutions are currently assisting a global client with the recruitment of a Director of Marketing. This position will be overseeing the whole department, mentoring and coaching of the team and reporting with senior management. **The successful Director of Marketing will be responsible for**: - Supervision of the marketing team...

  • Therapeutic Area- Genmed Regional Director Medical

    vor 1 Woche

    Zurich, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Pflegepersonal Befristet Spitex

    vor 3 Wochen

    Zurich, Schweiz Global Medical Vollzeit

    **EINFÜHRUNG**:Unser Beruf und unsere Leidenschaft «HR-Management». Global Medical ist ein eigenständiges Unternehmen der Interiman Group SA mit über 100 Mitarbeitenden, die an 21 Standorten in der Deutschschweiz ein komplettes Programm von Dienstleistungen im Bereich Human Resources anbieten. **Wir bieten Ihnen einen spannenden Temporäreinsatz in...

  • Stellvertretende Teamleitung Spitex

    vor 2 Wochen

    Zurich, Schweiz Global Medical Vollzeit

    **EINFÜHRUNG**:Unser Beruf und unsere Leidenschaft «HR-Management». Global Medical ist ein eigenständiges Unternehmen der Interiman Group SA mit über 100 Mitarbeitenden, die an 21 Standorten in der Deutschschweiz ein komplettes Programm von Dienstleistungen im Bereich Human Resources anbieten. **Per September oder zum nächstmöglichen Zeitpunkt...