Senior Medical Director, Pharmacovigilance

4 weeks ago

md united states Jobleads-US Full time
Company Overview At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody generating technologies, Multiclonics, to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients' lives. This is why we are committed to getting this right, with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great, and the patients are waiting. Join us and make an impact.Key Responsibilities Your role: Merus is seeking a Senior Medical Director to serve as the global safety officer for the pharmacovigilance and risk management of assigned investigational and/or marketed oncology products at Merus. This person will be responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. The global safety officer plays a critical leadership role in the program team through the product life-cycle, working in close collaboration with Pre-clinical Safety, Clinical Development, Biostats, Medical Affairs, Regulatory Affairs and other functions at Merus. They will work effectively with key stakeholders and business partners on strategy and tactical safety issues, and keep senior management informed of evolving safety profiles, plans, and execution issues. May represent Merus at internal and external meetings, including interactions with global regulatory authorities. The successful candidate will have demonstrated accountability and a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders either verbally or in writing with impact. The position reports to the VP of Pharmacovigilance/Head of Safety and is remote based but will be affiliated with the Cambridge, MA office location and will be expected to travel to the office as needed for meetings and other business needs. In this role you will:
  • Chair Safety Management Team for assigned products at Merus
  • Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with Pharmacovigilance staff, to include the following:
    • Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
    • Design, implement and ensure routine signaling activities, assessments and investigations are effectively completed and documented in a timely manner
    • Respond to product safety queries from all sources including ethics committees and regulatory authorities
  • Lead product benefit-risk assessment and presentation to the Safety Management Team and Executive Safety Committee and any needed actions, for example, IB update, update to patient safety information, or modifications to protocols
  • Lead Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams with critical roles which include:
    • Strategic advisement on clinical development plans, design of clinical protocols
    • Responsible for safety content of IB and ICFs and support of DSMBs
    • Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings
    • Content of Risk Management Plan/ REMS (as required)
    • Advisement on the design of post-approval safety studies
  • It is expected that the global safety officer will establish a high level of trust and collaboration with cross-functional counterparts in carrying out these activities
  • Ensure development and implementation of other department goals, policies and strategies in collaboration with the VP Pharmacovigilance, consistent with regulatory requirements and industry best practices
  • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities
  • Other job duties that may be assigned according to business needs
Skills, Knowledge and Expertise Your profile: We are looking for a candidate with:
  • MD, or MD PhD, or MD MPH required
  • Minimum 8-10 years of PV MD experience within the biotechnology or pharmaceutical industry is required
  • Strong background and previous experience in Product Safety/Safety Management Team (or similar model) lead (PST/SMT Lead) with strategy oversight is preferred
  • Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
  • High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
  • Expert 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
  • Experience and extensive working knowledge of individual case medical review, signal detection and evaluation, and clinical study safety management
  • Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
  • Experience with audits and inspection
  • Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization
  • Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail

Benefits Our offer We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you'll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you'll have the chance to help us close in on cancer – everything you do matters at Merus.#J-18808-Ljbffr

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