Director, Clinical Operations

BACK

Rain Therapeutics is committed to building a passionate team of core business leaders to execute on our vision to identify, and execute on the development, of novel therapeutic avenues for the treatment of cancer.  The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure.

Summary:

Responsible for leading the execution of the clinical development strategy for Rain’s programs beginning with lead program RAIN-32, a small molecule MDM2 inhibitor for patients with well-differentiated and de-differentiated liposarcoma, and other indications exhibiting MDM2 gene amplification or overexpression. RAIN-32 has completed clinical trials in certain solid tumors and hematological malignancies and has received FDA Orphan Drug Designation for patients with liposarcoma.

Tarloxotinib, a hypoxia-activated pan-HER inhibitor is in clinical trials for patients with HER2 activating mutations in non-small cell lung cancer, as well as a tumor-agnostic cohort for patients with NRG1, EGFR, HER2, and HER4 fusions. Rain is also developing a potential first-in-class inhibitor of RAD52 in the DNA Damage Response (DDR) pathway as a synthetic lethal strategy for tumors with BRCA1/2 mutations. 

The director position will help build and lead a clinical operations team to facilitate the management of the clinical trial process, including planning and execution of in-house or outsourced clinical trials. The Director of Clinical Operations will report to VP of Clinical Operations of Rain Therapeutics.

Critical Job Skills:

  • Responsible for the successful operations of assigned study teams to achieve the study objectives to the highest standards and on time and budget
  • Analysis and input into protocol writing, site identification and selection, and working with internal and external team members to deliver patients and high quality data, right through to finalization of the Clinical Study Report (CSR)
  • Conduct all tasks and activities in full compliance with regulatory requirements, GCP, good medical practice, and SOPs
  • Lead all study activities within the CST from study set-up, study plans, site initiations, data collection, ongoing site management and site close-out
  • Responsible for overall vendor management and performance, including defining and tracking study metrics
  • Monitor overall adherence to study protocols, timelines and objectives
  • Manage study budgets, contracts and forecasts
  • Identify program risks, and proactively create and implement mitigation strategies
  • Provide senior management with the necessary timely reports and presentations on progress and changes in scope, schedule, and resources
  • Work with internal team members in the development and implementation of compliance programs for clinical studies including SOPs
  • Manage and develop direct report(s) to achieve their goals and objectives as it relates to the assigned workload and accompanying objectives
  • Develop relationships with study Investigators to help support product development and represent Rain Therapeutics at meetings such as SIVs
  • Travel: Up to approximately 15%

Preferred Education and Experience:

  • Education: BS required; MS, PhD or PharmD degree is preferable
  • Experience: MS / PhD and 10 years managing clinical/operations/development in a pharmaceutical and/or biotechnology company demonstrating a broad background in those environments plus a minimum of 5 years managing clinical operations/development staff (BS + 12 years experience)
  • Experienced manager with a proven ability to interact with and train clinical research staff and vendor/site staff, and build constructive, trusting and respectful relationships with individuals at all levels internally and externally
  • Prior oncology therapeutic program experience is required
  • Prior experience with clinical quality and vendor audits/compliance is required
  • Prior experience with investigator sponsored studies is preferable
  • Familiarity and comfort with clinical concepts and practices regarding clinical research studies
  • Extensive knowledge of ICH/GCP Guidelines and regional regulations
  • Experience with data management and biostatistics and electronic platforms such as EDC and IRT, from database design to database lock and analysis
  • Demonstrated leadership, performance management, communication, and organizational skills

Qualities for Success:

  • Ability to perform job duties with minimal guidance
  • Successful oral and written communication and interpersonal skills
  • Demonstrated record of accomplishment in a compressed time frame; prioritizing tasks and delivering on deadlines with high performance standards and attention to detail
  • Ability to manage the needs of multiple internal and external partners and deploy the necessary resources and implement strategies to meet those needs
  • Managerial experience overseeing others in achieving corporate objectives
  • Experience working with small teams to execute on a clinical development strategy
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Manage and develop direct report(s) to achieve their goals and objectives as it relates to the assigned workload and accompanying objectives
  • Intellectually curious with courage to challenge and seek new ways to improve work
  • Ability to analyze and interpret data and develop written reports and presentations of those data
  • Possess strong critical thinking and problem-solving skills
  • Demonstrated leadership, performance management, communication, and organizational skills

Rain Therapeutics is an equal opportunity employer, and we’re proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.