Associate Director, PV Scientist

Company: Moderna Therapeutics
Location: Cambridge
Posted on: April 5, 2021

Job Description:

(Contract) Associate Director, PV Scientist Cambridge, Massachusetts Clinical Development The Role:Join Moderna Therapeutics' enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic input, support in clinical trial, perform signal management activities and operational support for all Moderna products throughout the life-cycle. In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.Here's What You'll Do:

• Providing therapeutic area PV support for Moderna's developmental products in close collaboration with senior PV, Clinical and Medical personnel.
• Oversight of day to day PV operational activities for Moderna's investigational products.
• Develop and maintain processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency and compliance with applicable global pharmacovigilance regulations.
• Oversight of vendor in case management and aggregate reports.
• Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.
• Represent Pharmacovigilance on clinical teams and initiatives both within and across functional areas.
• Assist in usual pharmacovigilance activities including ongoing signal monitoring and regulatory activities.
• Facilitate cross-functional Safety Review Committee meetings, including coordinating aspects of signal evaluation/safety review activities.
• Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.
• Participate in writing of aggregate safety reports (e.g., DSURs), as required.
• Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.
• Assist with writing and maintenance of Safety Monitoring Plans and Pharmacovigilance Agreements.
• Oversight of signal evaluation/safety monitoring activities.
• Assure oversight for the review of aggregate safety data to ensure accuracy, integrity and completeness.Here's What You'll Bring to the Table:
  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
  • Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years' experience in PV - experience in vaccine development is required
  • Knowledge of MedDRA terminology and its application
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
  • Experience in the preparation and authoring of individual and aggregate safety reports
  • Demonstrated ability to develop, execute and follow-through complex projects to completion
  • Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated, detail oriented and strong problem-solving ability
  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
  • Excellent written and verbal communication skills with the ability to interact across multiple functionsAbout Moderna : In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-DNI- Posted 15 Days Ago Full time R4043 About Us Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Keywords: Moderna Therapeutics, Cambridge , Associate Director, PV Scientist, Executive , Cambridge, Massachusetts