JOB OBJECTIVE: The Senior Director, Clinical Development will play an important leadership role in Usona’s overall clinical development strategy and execution and ensuring that all activities occur in compliance with the appropriate safety standards/regulations and organizational goals. This individual should have a strong mission orientation and desire to work in a dynamic, highly collaborative organization. He/she will contribute to both the design and execution of project plans and will assimilate/apply input from multiple functional areas (e.g., chemistry/CMC, nonclinical, regulatory) and Key Opinion Leaders (KOLs).
1. Manages the design and implementation of one or more clinical development plans, based on sound medical and scientific principles and thorough knowledge of all compliance/regulatory requirements.
a. Acts as a clinical interface and actively solicits KOL interactions related to the molecule(s) and disease area(s); partners with other functions in these activities as required to ensure that broad cross-functional perspectives are incorporated into development plans and protocols as appropriate.
b. Builds and provides estimates of project timelines and costs in conjunction with Usona leadership, and manages resource availability and execution of approved development plans with regard to schedule, budget, and quality. Coordinates input from CMC, nonclinical, and regulatory/compliance functions to ensure proper feasibility and planning.
c. Responsible for regulatory strategy, submissions, and agency engagement, also acting as an individual contributor for writing and review as needed. This includes responsibility for the design, analysis, interpretation, and scientific data reporting in protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
d. Conducts and maintains program-level risk assessments and manages links between projects.
e. Reports progress to key stakeholders including regular program communications.
f. Stays abreast of professional information and technology through conferences, scientific literature, and other available training to augment expertise.
2. Responsible for the oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
a. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events (SAEs) per regulations and organizational policies – including SAEs related to Usona’s Investigational Drug and Materials Supply Program.
b. Ensures timely delivery of all clinical studies within overall program plans and works to resolve study issues that cannot be resolved at study level by the Clinical Operations Manager (COM) and/or Clinical Trial Manager (CTM).
c. Develops project/study outsourcing strategies in collaboration with Clinical Operations and Strategic Partnerships teams. Ensures that functional experts are engaged where appropriate throughout the programs’ lifecycles to ensure optimal planning, feasibility, issue resolution, and delivery to plans.
3. Ensures that all programs are delivered in accordance Good Clinical Practice, pharmacovigilance standards, standard operating procedures and all other quality standards in conducting research. Requests that quality assessments are conducted as needed. Promotes a culture of inspection-readiness and transparency in all program and study delivery activities.
4. Understands and complies with all ethical, legal and regulatory requirements applicable to our business.
1. MS, PhD, or MD (or non-US equivalent of MD degree) with relevant therapeutic specialty in an academic or hospital environment.
2. 15+ years of significant experience in managing clinical research projects or equivalent.
3. In-depth understanding of clinical trial methodology and protocol design, project/program development, quality requirements (FDA, ICH and USP guidances/guidelines), and associated processes.
4. Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team, and organizational objectives.
5. Demonstrated skills in internal and external collaboration among cross-functional teams, vendors, and scientific and clinical advisors.
6. Ability to manage change with a positive approach and flexibility to the challenges of change for the individual, team, and organization.
1. Ability to use telephone and computer equipment.
Diversity is important at Usona. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.