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Senior Director, Clinical Operations (Oncology)

nimbustherapeutics · 22 days ago
$125k+
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Full-time
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Nimbus has an outstanding opportunity for a Senior Director, Clinical Operations (Oncology) to join our team. This individual is responsible for playing a lead role in the implementation of Nimbus’ Oncology studies and programs, including leading the management, planning and implementation of clinical studies and programs to set the direction for the Clinical Operations organization.  Additionally, this role will lead and develop a team to achieve all milestones an deliverables from protocol creation to study completion and ensure that studies are planned and conducted efficiently and with the highest quality.  You will report to and partner closely with our SVP of Oncology Development.

In This Role, You Will:

  • Provide clinical operations leadership, and oversight for Clinical Trial Manager(s), Clinical Research Associate(s) and other personnel that support quality execution of Nimbus’ Oncology clinical trials
  • Execute study activities including CRO selection and negotiation, site identification and selection, clinical supply planning, and budget planning and management
  • Support design, implementation and management of clinical operations systems and infrastructure, including quality systems (ex: standard operating procedures) and the development of current and future team members
  • Develop and maintain strong relationships with investigators, clinical site staff, and vendors, both in the US and globally
  • Ensure operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials; ensuring all activities are completed in accordance with ICH GCP regulations, health authority regulations and SOPs
  • Author and/or contribute to key study documents: protocols, informed consent forms, study governance committee charters (ex: data monitoring committee) and clinical study reports
  • Serve as oncology clinical operations subject matter expert, representing clinical operations internally and externally
  • Provide input into and review regulatory documents related to the drug development process and preparation for key regulatory meetings as needed
  • Lead the proactive identification, assessment and management of clinical study challenges and risks to ensure trial success and compliance
  • Oversee the preparation and management of clinical trial budgets.Support Finance/Development teams by forecasting clinical trial budgets and timelines, both quarterly/annual budgets and long-range planning
  • Collaborate with contracts team to ensure requests for proposals (RFPs) meet user requirements and all contracts with study sides and vendors are efficiently executed
  • Contribute to the development of corporate initiatives, specific Business Development activities, and various organizational initiatives in Clinical Development

These Qualifications Will Help This Role Be Successful:

  • BA / BS degree in relevant healthcare or scientific discipline with 15+ years Clinical Operations experience within the biopharmaceutical industry
  • Demonstrated track record leading and overseeing multiple Oncology studies, particularly within early development phases (First-In-Human / Phase 1 & Phase 2)
  • Extensive experience managing CROs and other third-party vendors in support of clinical trial execution
  • Experience and desire mentoring and guiding clinical operations team members
  • Thorough knowledge of ICH GCP guidelines and other applicable regulatory rules and guidelines related to medical terminology and clinical research
  • Demonstrated excellent in project/program management and matrix leadership; ability to be both a strategic leader and hands-on problem solver
  • Demonstrated scientific acumen, demonstrated analytical abilities, sound clinical judgment, scientific credibility, and strong integrity consistent with the company’s values
  • Excellent communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
  • Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment

 

A Snapshot of Nimbus 

Our Science  

At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.  

Our Culture 

Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.  

Our Company 

Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Boston, Massachusetts. Learn more about us by going to www.nimbustx.com 

Join Nimbus. We are making a difference and you can too. 

At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.

 

Last updated on Jul 3, 2024

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