Director of Translational Development Operations
Director of Translational Development Operations (San Diego, California)
COMPANY OVERVIEW: Oncternal (Nasdaq: ONCT) is a clinical-stage San Diego-based oncology company developing first-in-class therapies targeting novel pathways, ROR1 and ETS, to address critical unmet medical need in patients with leukemia, lymphoma, and solid tumors.
SUMMARY OF POSITION: As Director of Translational Development Operations, you will work collaboratively with cross-functional teams to advance novel cancer therapy development programs within established timelines and budgetary targets.
This position will be part of the research group and will report to the Chief Scientific Officer.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Implement and manage initiatives, as well as provide operational and translational support to the key functional teams and stakeholders.
- Generate/edit technical reports and other documents to support IND filings and patent applications.
- Facilitate meetings effectively, maintain meeting minutes, and generate action items, follow-up, and escalate any issues for all assigned projects.
- Plan, support, and execute scientific publication strategy.
- Develop and execute an innovative translational medicine and biomarker strategy.
- Design preclinical in vivo studies utilizing disease models that have pharmacological validity in terms of efficacy, dosing, endpoints, and biomarkers of human efficacy.
- Provide oversight on scientific management of preclinical efficacy, safety, toxicology and DMPK studies supporting early drug development.
- Draft RFPs, solicit and negotiate quotes, manage vendors and consultants to complete Translational Medicine studies for the various programs.
- Provide cross-functional study management support for preclinical programs including development and management of timelines and leading regular team meetings.
- Communicate project status and issues ensuring project team goals and regulatory deliverables are met.
- Proactively anticipate obstacles and devises and implements solutions to achieve project goals through management of cross-functional relevant team members.
- Provide guidance to team members to objectively assess and resolve project issues to improve project effectiveness.
- Perform other duties as assigned.
- Ph.D. degree in biological sciences or related disciplines with at least 5 years industrial experience.
- Extensive knowledge and understanding of the drug development process.
- Experience in the biotechnology or pharma industry with a primary focus on translational science.
- Knowledge and experience working with small molecule drugs as well as biologics, i.e. antibodies and cell therapies.
- Understanding of cancer biology principles and familiarity with solid tumors and hematological malignancies.
- Expertise in disease-relevant biomarker discovery and validation strategies.
- Familiarity with diagnostics approaches, including LDT, CLIA, CDx.
- Demonstrated experience managing project deliverables, scope, resources, and timeline to ensure the project remains on schedule and within scope.
- Demonstrated ability to identify and analyze project risks and help guide teams to develop appropriate mitigation strategies.
- Experience with design of IND-enabling studies and supervision of outsourced studies.
- Excellent cross functional communications skills and a decisive yet collaborative leadership style to drive results while managing relationships at all levels of the organization.
- Excellent written, verbal, interpersonal and communication skills necessary.
- Proficiency in MS Office and MS Project is required.
- Strong problem-solving, troubleshooting, and organizational skills.
- Both effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timeline.
- Self-starter who works with a sense of urgency and functions as a strong team player effectively working with other disciplines.
- Willingness to work remotely (at least during COVID19 pandemic) and, when appropriate, travel as needed to support a variety of Company initiatives.
Oncternal Therapeutics is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other protected status