healthcare
Posted 2 hours agoAssociate Director, Clinical Development
at Natera
United StatesRemote
Responsibilities
- Drive the design and timely execution of clinical research plans, including clinical studies and investigator-initiated studies, research projects
- Build relationships with KOLs, consortiums, clinical site staff, and external partners to fill identified data gaps
- Develop clinical project execution timelines and provide status updates to senior management to ensure timely delivery of program milestones.
- Drive contracting, including budget approvals, with academic centers and community practices participating in Natera research studies.
- Lead project resource planning, reforecasting, and program milestones.
- Ensure that employees are appropriately trained, developed, and coached to comply with study requirements, company policies, and respective agency regulations
- Advocate for and drives timely completion of assigned goals and organizational changes within the organization
- Assure a climate of equal employment opportunity and promote an equitable workplace.
Requirements
- Completes required work independently as well as managing work through direct reports
- Must maintain a current status on Natera training requirements.
- Employee must pass post offer criminal background check.
- B.S. degree in relevant scientific discipline or related field; advanced degree preferred
- experience in managing clinical research in a leadership role. Established
- experience managing staff and setting department objectives •
- Experience and knowledge of oncology a plus. •
- Experience with regulated in vitro diagnostic is a plus.
- Knowledge of applicable Regulations, and GCPs governing the conduct of clinical trials is required.
- Ability to thrive and flourish in an entrepreneurial company environment requiring “hands-on” leadership.
- Physical and intellectual energy, a sense of urgency, and a strong work ethic.
- Learns and applies in-depth knowledge of Natera’s business and corporate objectives to analyze situations and available data in order to make effective plans to Sr. Management that are aligned with Natera’s goals and business objectives.
- Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations without damage to relationships.
- Expertise and current training in Good Clinical Practice (GCP).
- Proficient in MS Word, Excel, PowerPoint and clinical trial databases.
- Must have current GCP training
- Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
Experience
- 8 + years of clinical research experience, including at least 3-5 years of
Benefits
- The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.
- Remote USA $144,900 — $181,100 USD OUR OPPORTUNITY
- Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
- benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other
- benefits include pregnancy and baby bonding leave, 401k benefits, commuter
Contact
- For more information, visit www.natera.com .
- Link: https://www.natera.com/notice-of-data-collection-california-residents/
- Please be advised that Natera will reach out to candidates with a @ natera.com email domain ONLY.
Additional details
- The Associate Director, Clinical Development is a leadership role responsible for executing Natera’s clinical development objectives. The core
- responsibilities of the role include outlining clinical research
- requirements (clinical study plans, protocols and supporting documents), forming relationships with centers conducting research in organ transplant, women’s health, and oncology, and driving on-time execution of clinical research projects.
- This role will focus on delivery of complex or multi-center investigator sponsored studies and consortium projects. PRIMARY RESPONSIBILITIES:
- Participate in due diligence activities to evaluate external opportunities that support Natera’s business objectives.
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
- Manages a team (usually 3-6) working on a variety of routine and complex tasks
- Responsible for staffing assigned projects and for the professional development of direct reports.
- Makes recommendations to management on matters related to human resources, budget, and department operations
- Leads by example to create a positive work environment by encouraging mutual respect, accountability, smart risks, and innovation on a functional and project level.