Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Director, Digital Clinical Devices & Technologies

Expired Job

Ultragenyx Pharmaceuticals Brisbane , CA 94005

Posted 5 months ago

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary

ultradedicated Your biggest challenges yield rare possibilities

In this unique position, reporting to the Vice President & Global Head of Disease Monitoring Programs (DMPs) & Ultra Programs and closely collaborating with the Director of DMP Technology and Data Management, you will be at the forefront of implementing mobile/digital clinical devices and technology to Ultragenyx's innovative, patient-centric, and observational DMPs; within these programs we work on multiple, well-funded projects. The senior manager will develop and implement a mobile technology roadmap aligned with the company's vision, feedback of patients and their advocacies, and the latest technology trends (web and app based); focus will be on aspects of data reporting as well as access to reports in graphic and other (mobile) formats. In this role, the senior manager will collaborate internally with IT and Data Management teams and externally with contracted vendors. The best candidate will possess a strong technical acumen and proven experience with designing, building, and operationalizing mobile applications, preferably in a life science environment.

Responsibilities including, but not limited to:

  • Drive the development and implementation of a roadmap of mobile applications for DMPs; this includes data reporting and access to (real-time, mobile) reports

  • Be the point of technical contact for the DMP team and connect with other departments in the organization proactively (e.g. IT, Procurement, Data Management)

  • Manage vendors involved in technical, innovative mobile applications, and continuously monitor their performance

  • Support the data collection using digital devices (mobile phone, apps and sensors) in DMPs and work closely together with the DMP Data Management team

  • Evaluate new technologies in close collaboration with the IT and Data Management teams

  • Respond flexibly and adaptively to the needs of the organization through a culture of continuous improvement and innovation

  • Review relevant proposals and translate these into internal budgets

  • Vendor management

Technical Requirements &

  • Bachelor's, Master's Degree in Information Technology or related field

  • Must be a champion of new, innovative ideas combined with experience in wearable technology, preferably in a life science area

  • Proven ability to define and execute a successful technology-product roadmap

  • Experience with ePRO (electronic patient-reported outcome) is preferred

  • Clinical Data Managers with ePRO and technology experience are welcome to apply

  • Will have excellent project management skills, exceptional attention to detail and accuracy and is highly organized

  • Ability to independently reprioritize tasks to meet deliverables

  • Knowledge of data governance, preferably in a health care/GCP environment

  • Must be highly skilled in MS Office (Word, Excel, PowerPoint and Outlook)

  • Highly self-motivated and influential

Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to:


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director / Director Drug Safety Surveillance (Rare Disease)


Posted 4 weeks ago

VIEW JOBS 12/19/2018 12:00:00 AM 2019-03-19T00:00 Associate Director / Director, Drug Safety Surveillance (Rare Disease) Location Brisbane, California Apply BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin's Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives. The Associate Director / Director, Drug Safety Surveillance is responsible for strategic leadership and medical oversight of BioMarin PV (BPV) activities in collaboration with the EU Qualified Person for PV (EU QPPV), BPV colleagues, and applicable cross-functional specialists, with special focus on identification, evaluation and management of safety risks throughout BioMarin products lifecycle. RESPONSIBILITIES: * Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) involving BioMarin products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting. * Assist in follow-up of important ICSRs to ensure relevant information is sought. * Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals. * Participate in the development and revision of safety signal surveillance, risk management plans and product labeling throughout BioMarin product lifecycle. * Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report). * Serve as or support Safety Management Team Leader and collaborate with Clinical Teams, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed. * Collaborate with Medical Directors in both Clinical Development and Medical Affairs to provide expertise in both US and ex-US post-marketing safety surveillance requirements (e.g., registries). * Review and advise on safety/medical information in advertising and promotional materials as needed. * Help prepare and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other documents. * Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements. EXPERIENCE: Required Skills: * Excellent medical knowledge with the ability to interpret, synthesize and communicate complex medical/pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs. * Minimum 1-3 years of experience in international pharmaceutical company for Associate Director level. * Minimum 3-5 years of experience in international pharmaceutical company experience for Director level. * Experience reviewing cumulative safety data and completing signal management activities. * Strong working knowledge of US and ex-US PV requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines). * Experience with pre- and post-marketing ICSR processing and aggregate safety reporting. * Knowledge of MedDRA terminology and its application. * Experience in the preparation of PSURs, Pharmacovigilance Plans, Risk Management Plans, and Reference Safety Information. * Thorough understanding of the drug development process and context applicable to safety surveillance. * Excellent verbal and written communication skills, including formal presentations. * Sound organizational skills with the ability to prioritize tasks. * Excellent interpersonal, team management and leadership skills. * Proficiency in Word, Excel, and safety databases. Desired Skills: * Managerial experience * Experience in PV EDUCATION: * Medical degree (e.g., MD, DO, PhD, Pharm D.) with the appropriate clinical and pharmacovigilance experience Biomarin Brisbane CA

Director, Digital Clinical Devices & Technologies

Expired Job

Ultragenyx Pharmaceuticals