At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.
To achieve this goal, our vision is to lead the future of rare disease medicine.
For us, this means going where other biopharma companies wont go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx.
We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work.
Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
During the COVID-19 Outbreak, we are committed to our hiring process.
The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.
Position Summary: ultracurious – Apply your biggest ideas in courageous ways Click here to view a job description with full details.
https://ultragenyxpharma.box.com/s/eumtqg725mt3qirn0n1rvjpx7pvjmwsy Ultragenyx is looking for a Medical Director of Clinical Development with the passion and creativity to develop great medicines for rare and ultra-rare diseases.
The ideal candidate is a physician with some industry experience in drug development who is enthusiastic about applying their knowledge to the cause of patients around the globe who have no approved therapies for their disease.
– Rare diseases affect over 350 million people world-wide with only 400 therapies – Many are severe, chronic, and progressive, with high mortality rates – Most diseases have a on patients, their families, and society You will with excellent clinical knowledge who is looking to help be part of a creative team to bring the drug development processes to a successful outcome.
You will help develop clinical research and development programs including important trials and filing activities.
You will be an liaison between company and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other important partners and partners.
You will ready for a career defining experience and have the passion to improve several therapeutics for serious debilitating diseases to final approval.
Responsibilities to include: Direct involvement in trial design of Phase I/II/III research trials targeting rare or ultra-rare diseases, requiring expertise and stewardship in the areas of Endocrinology / Metabolism / Bone Develop clinical study protocols and associated clinical study documents in compliance with clinical development plans, GCP, and good medical practice.
Provide medical surveillance and follow-up within clinical trials of Adverse Event (AE) and Serious Adverse Event (SAE) reporting; provide medical guidance and guidance for contract research organizations and study investigators.
Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory values; maintain an ongoing assessment of the safety profile, and efficacy data.
Author and review written materials and provide editorial comments for clinical study reports, regulatory updates, product labeling and manuscripts.
Collaborate in developing global regulatory plans and documents; meaningfully contribute to meetings with regulatory agencies worldwide in partnership with regulatory affairs.
Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
Ensure that operational activities are conducted in compliance with all appropriate regulatory or statutory requirements and observing the scientific standards, ethical and professional values, management philosophy, and established priorities and policies of the Company.
Follow important developments and trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program.
Requirements: MD is required.
Formal training in the areas of Pediatrics / Internal Medicine / Genetics / Bone and Metabolism / Endocrinology.
Some clinical experience in drug development (2 years ), ideally within rare disease or orphan indications.
Experience with trials though NDA / BLA.
Global clinical development experience and global filing experience.
Demonstrated ability to work in a matrix environment with teams.
Up to 20% annual travel (domestic and international) is required for this position