Program Manager, Early Access & IST

Ultragenyx Pharmaceuticals Novato , CA 94998

Posted 2 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

ultrainnovative Tackle rare and dynamic challenges

Ultragenyx is looking for a driven, compassionate and innovative Program Manager (PM) for the global Early Access (EA) and Investigator Sponsored Trial (IST) programs in the Global Medical Affairs department. This role is vital to achieving program goals and offers an opportunity to work on a variety of projects that reflect the company's patient focused mission.

The PM is accountable for the operational strategic planning, oversight and delivery for one or more IST and EA programs. The PM is accountable for the line management of Ultra Programs staff, including development, coaching, talent planning and performance management. The PM also participates in functional governance, including resourcing and staffing.

Responsibilities including, but not limited to:

  • Leads the development and execution of the operational strategies of the global Investigator Sponsored Trial (IST), External Research and Early Access (EA) programs in accordance with the program development plans

  • Leads the cross-functional review committee and participate in the program management meetings

  • Oversees Company operational activities for ISTs and Early Access

  • Lead the Ultra Programs team to ensure effective development, implementation and execution of expanded access clinical trials within agreed timelines, resources and budgets

  • Participates in strategy development, protocol, CRF development, Clinical Study Report preparation, and NDA submission, as appropriate

  • Oversees program timelines, budgets and product demand

  • Evaluates resourcing needs for assigned programs

  • Identifies program risks, develops and implements mitigation strategies for assigned programs

  • Represents Ultra Programs on the Development Sub-teams and Program Core Teams, as applicable

  • Prepares metrics and updates for management

  • Facilitates the CRO/vendor selection process for outsourced activities

  • Oversees CRO interactions, including sponsor oversight of operational functional activities, such as case management, training and monitoring

  • Partners with Pharmacovigilance to ensure compliant Investigator/Physician safety reporting

  • Ensures employees and contractors are appropriately trained to comply with company and regulatory standards

  • Participates in the development and implementation of corporate and department organizational goals

  • Participates in and/or lead working groups or initiatives, as required

  • Mentors Ultra Programs team members

  • Possibility to manage Ultra Programs direct reports in the future

Technical Requirements &

Skills:
  • Bachelor's degree or relevant experience required

  • Experience in rare diseases is a plus, but not required

  • Willingness to address urgent treatment requests when needed

  • 8+ years of experience in drug development, including 4+ years of clinical trial or clinical research management experience

  • Proven ability to provide operational expertise to a clinical development program with experience in overseeing CROs, specialty labs, outside vendors and international trials

  • Late Phase or Phase IV experience a plus, but not required

  • Familiar with advanced concepts of clinical research with demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA and Country regulations/ICH guidelines, is required

  • Must possess excellent planning and interpersonal skills with a high degree of customer focus towards internal and external stakeholders and have the ability to build and maintain positive relationships with management, peers, and direct reports

  • Proven ability to lead a program or study team and ability to deal with time demands, incomplete information or unexpected events

  • Excellent written and verbal skills required; Must display strong analytical and problem solving skills

  • Willing to travel domestically and internationally

  • No previous experience in a supervisory role required

People Management Skills:

  • Clarify Direction & Priorities: Set clear direction for your direct reports aligned with functional and corporate goals. Reprioritize work, as needed. Enable others to do their job well by communicating information and making decisions in a clear, timely manner.

  • Partner & Collaborate Effectively: Listen to and value others' thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.

  • Support Learning & Growth: Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others.

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: talentacquisition@ultragenyx.com.

#LI-YG1


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Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com. #LI-YG1 Ultragenyx Pharmaceuticals Novato CA

Program Manager, Early Access & IST

Ultragenyx Pharmaceuticals