ultracurious – Apply your biggest ideas in courageous ways
Ultragenyx is looking for an experienced Senior 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 experience of a global drug development program and global filing experience 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 profound impact on patients, their families, and society
The individual will be a self-starter with excellent management and leadership capabilities who is seeking to lead and be part of an innovative team that will drive the drug development processes from start to finish.
Reporting into the VP, Clinical Development will be responsible for the development and execution of clinical research and development programs including the leadership of the pivotal trials and filing activities.
This position will serve as a key liaison between company and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.
The successful candidate will be ready for a career defining experience and have the passion to drive a number of therapeutics for serious debilitating diseases to final approval.
Responsibilities, including but not limited to:
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 & CNS/Neurology
Directly supervise and monitor trial conduct.
Work closely with all functions of the organization and external partners to manage trial logistics.
Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs.
Identify opportunities for external collaboration.
Follow important developments and relevant 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.
Develop effective relationships with external providers.
Provide clinical assessments of potential in-licensing assets, identifying novel therapeutics opportunities as well as critical study design and execution challenges.
Author, review written materials and provide editorial comments for clinical study reports and manuscripts.
Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
Design and develop clinical study protocols and associated clinical study documents and monitor required documentation in compliance with clinical development plans, GCP, and good medical practice.
Participate in the selection of clinical investigators; providing guidance to investigators on a study.
Provide medical supervision for contract research organizations and protocol procedures.
Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory values; maintaining an ongoing assessment of the safety profile, and efficacy data as appropriate.
Provide medical surveillance on Adverse Event (AE), Serious Adverse Event (SAE) reporting, and follow-ups.
Direct and oversee the overall strategy for clinical drug product development and collaborating with Regulatory personnel in IND, CTA, and NDA submission activities as well as submission of IND safety reports.
Lead the clinical aspect of interactions with regulatory agencies worldwide
Participate in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions.
Assist with due diligence of new scientific developments.
Analyze and interpret study data for abstracts or publication as required.
Support corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees/task groups.
Collaborate on overall company strategy and in licensing of new programs.
Work with the financial group as needed to assist with the production of budgets and timelines for the clinical development team.
Plan and lead clinical focus groups to create clinical trial and protocol designs.
Ensure that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, and established priorities, policies, and practices of the Company.
Lead the disclosure of scientific content for the preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling.
M.D. or equivalent degree is required. Formal training in the areas of Pediatrics / Internal Medicine / Genetics / Bone and Metabolism / Endocrine / Neurology is desired.
A minimum of 5+ years (10+ years strongly preferred) of clinical and managerial experience in drug development, ideally within rare disease or orphan indications.
Experience with trials though NDA / BLA strongly preferred.
Global clinical development experience required and global filing experience strongly preferred.
Technical (Medical and Scientific) experience evaluating targets/agents for in-licensing or internal development desirable.
Experience supervising physicians and/or scientific staff in a management or team leader capacity highly desirable.
Excellent interpersonal and public speaking skills are required for this high visibility position.
Demonstrated ability to work in a matrix environment with cross-functional teams.
Up to 20% annual travel (domestic and international) is required for this position.