Careers

Rain Therapeutics Inc. (“Rain”) is committed to empowering leaders with an entrepreneurial spirit that thrive in small team environments. Our hiring strategy requires recruiting top talent that seek an opportunity to tackle tasks independently, and develop creative solutions across the business. Our employees need to be passionate about developing therapies in cancer to save lives.

Rain is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.

If you are interested in joining the Rain team, please contact us at careers@rainthera.com

Open Positions:

Director, Clinical Operations

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.

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Sr. Director, Head of Regulatory Affairs

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 treatments for patients with cancer.  Rain is committed to the development of novel cancer treatments by bringing together people who are passionate, creative, and experienced at building a vision and executing on strategy.  Rain is shaped by self-motivated entrepreneurs who like to build teams to achieve goals for the benefit of patients suffering from diseases with unsatisfactory treatment options.

Summary:

The role will be responsible for developing and leading regulatory strategies to ensure the successful development and commercialization of novel therapeutic oncology products.  The position will also be responsible for building a high performing regulatory team and for identifying appropriate vendors to support business critical activities.  Key to this role will be furthering the development of tarloxotinib (Tarlox) for non-small cell lung cancer (NSCLC) harboring EGFR / HER Exon 20 insertion mutations.  The right candidate will be highly skilled at communicating with, and influencing, cross-functional colleagues in order to guide the team toward regulatory milestones.  The Senior Director, Regulatory Affairs will report directly to the CEO of Rain Therapeutics.

Critical Job Responsibilities:

  • Represent Regulatory Affairs when interacting with various company departments to manage activities and coordinate the preparation of regulatory submissions
  • Provide strategic regulatory advice, interpret guidance, and apply precedent where applicable
  • Build the Regulatory function and advise corporate management on regulatory opportunities during product development
  • Serve as the company contact with major health authorities, including FDA
  • Lead and facilitate meetings or other interactions with health authorities
  • Oversee regulatory vendors supporting operational activities
  • Lead the development of SOPs affecting core Regulatory deliverables (DSUR, 1572 submissions, etc.)
  • Identify regulatory risks and threats while developing mitigation strategies
  • Remain current with FDA and international regulatory guidance relevant to oncology and orphan drug development

Preferred Education and Experience:

  • 8+ years in Regulatory Affairs, including 2+ years as the US/Global Regulatory Leader for clinical-stage development programs
  • Oncology drug development experience highly desirable
  • Experience leading FDA meetings and teleconferences required
  • Hands-on experience working in small companies and small teams desirable
  • Highly proficient oral and written communication and excellent interpersonal skills required. A proven influencer
  • Desire and experience to build a regulatory function from the ground up, tapping vendors where appropriate
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment is critical
  • Intellectually curious with strong critical, strategic, and analytical thinking skills
  • Demonstrated record of accomplishment in a dynamic environment through an ability to prioritize

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.

Apply for This Position

Sr. Director of Drug Product Development and Manufacturing

Rain Therapeutics is committed to building a passionate team of core business leaders to implement 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.

The Sr. Dir., Drug Product Development and Manufacturing will lead drug product activities for all of Rain Therapeutics’ small molecule programs.  This individual will be responsible for the company’s CMC projects in terms of the development of formulations and processes of the drug products.  This individual will work independently to lead all aspects of drug product development activities in contract development and manufacturing organizations (CDMOs) from IND submission, clinical supply through Phase 3 and lead successful NDA submissions.  The individual will ensure that the content and quality of regulatory submissions meets the requirements in all markets specified by the regulatory requirements meeting needs of clinical or commercial teams.  Successful technology transfer of products to commercial manufacturing sites, process validation and support for the R&D responsibilities for pre-approval inspections will be ensured for all projects developed.  The successful candidate will interface with CMC and other Rain departments, ensure adequate staff are in place and may supervise direct reports to support CMC activities.  Develop, coach and lead associates to create high performing teams.  The individual will prepare drug product related project plans, timelines, budget projections, and assure development activities proceed in alignment with budget to achieve company goals. 

Rain is seeking an enthusiastic, driven, and diligent candidate who is a hands-on, detail-oriented individual who will partner well across all business functions and with corporate partners within the rapidly growing enterprise.  The successful candidate will have a stellar work ethic, the flexibility, and organizational skills to manage numerous and sometimes competing responsibilities of varying urgency within a fast-paced environment. 

The Senior Director will report directly to the Senior Director.

Key Requirements:

  • BS/MS degree in Chemistry, Pharmaceutics, Chemical Engineering, Pharmaceutical Chemistry, or related scientific disciplines with 15+ years of experience in the Pharmaceutical or Biotech industry with the focus on the small molecule drug product development and manufacturing 
  • Ph.D. with 10+ years of experience in the Pharmaceutical or Biotech industry with a focus on the small molecule drug product development and manufacturing 
  • Experience in writing CMC documents for regulatory submissions (IND/NDA/MAA)
  • A proven track record in developing and scaling up oral solid dosage forms including immediate, modified, and controlled-release formulations for tablets and capsules from pre-IND through Process Validation using the Quality by Design (QbD) concepts and design of experiments (DoE) 
  • Must have NDA preparation experience 

Position Description

  • Oversee contract development organizations (CDMOs) to lead development and optimization of drug product formulations to support the program from phase I clinical through commercial launch 
  • Review and approve master batch records, executed batch records, manufacturing deviations and investigations in conjunction with quality assurance.
  • Provide on-site technical Man-In-Plant (MIP) support to oversee manufacturing activities. 
  • Generate and/or review experimental plans and lead drug product development activities from research formulations, IND-enabling studies, preparation and optimization for registration and commercialization. 
  • Analyze and summarize complex data sets, including the use of appropriate statistical tools for the identification of CPPs and CQAs, development of drug product specifications and shelf-life estimates for drug product formulations. 
  • Generate and/or review Process Validation documentation, including Product Validation Master Plans, Statistical Product Sampling Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols in conjunction with engineering, analytical and quality assurance representatives.
  • Prepare technical reports in support of planned regulatory submissions including INDs and NDAs.
  • Write, review, and approve CMC portions of study reports and manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines.
  • Assist in supply chain logistics for drug product manufacturing activities.

Preferred Qualifications

  • Extensive experience in product development, clinical supply, and registration batch manufacturing for oral solid dosage and aseptic liquid or lyophilized infusion product development
  • Experience in the contract manufacturing environment with an in-depth knowledge of unit operations for the small molecule drug products including blending, granulation, encapsulation, compression, and tablet coating
  • Experience in sterile product development, including formulation, filling, lyophilization and associated container closure systems
  • Experience in formulation and process technologies by utilizing the enabling formulation approaches to enhance the bioavailability of the BCS class 2 compounds 

Qualities for Success

  • Ability to accurately forecast project budgets and timelines, and manage projects within budget 
  • Ability to effectively work independently in a team environment and demonstrate substantial experience with managing external CDMOs to meet the timelines within the approved budget 
  • Effectively work within the Development department and with cross-functional team leaders to achieve corporate and program goals 
  • Communicate project status and concerns to management and project leadership
  • Develop, mentor and lead associates across CMC and development functions
  • Contribute to project plans for delivering the CMC strategy and project objectives
  • Successful oral and written communication and interpersonal skills
  • Very strong presentation skills, including preparation of presentation materials in slide format
  • Ability to travel up to 30% of the time

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.

Apply for This Position

Sr. Director / Director, Program Management

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 creating and maintaining a corporate roadmap and project plan across all functional groups for the execution of Rain’s objectives for Rain’s lead program, RAIN-32.  The Sr. Director / Director of Program Management will engage with all groups at the Company and be required to ensure frequent status updates on documented deliverables and tasks to preserve the company-wide action plan for RAIN-32.  Meticulous attention to detail is a critical quality of the position, along with proficiency with new forms of technology to ensure adequate communication across the Company. This individual will work closely with the project team members representing nonclinical, clinical, regulatory, CMC, quality, legal and finance departments in a matrix team environment to develop concise strategic development proposals, integrated project plans, and manage and track key project deliverables.  

The Senior Director of Program Management will report directly to the CEO of Rain Therapeutics.

Critical Job Skills:

  • Spearhead the creation of a global project plan and Gantt chart to manage all deliverables for the RAIN-32 program, including, but not limited to:
    • Regulatory authority discussions and filings
    • Manufacturing timelines
    • Clinical Development timelines
    • Non-clinical research efforts
  • An amenable personality to be demanding of groups on progress updates while successfully managing relationships
  • Strong writing skills and a comprehension of writings as a means to manage relationships through written forms (i.e. emails and other)
  • Manage a network of consultants when needed
  • Technological proficiency and amenability to always search for new technologies that enhance Rain’s ability to gather and present information to interested stakeholders
  • Passion to learn details about all the functional groups within the company
  • Incorporate budgetary considerations in project planning and timeline considerations to develop scenarios for capital utilization
  • Other responsibilities to ensure full execution of the corporate CMC objectives
  • Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation
  • Manage Cross-Functional Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions (meeting minutes)
  • Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities
  • Work closely with and build strong working relationships with cross-functional team members to develop a collaborative team environment and manage timelines for regulatory submissions (IND/NDA/MAA, etc.)
  • Assist finance and functional area leads in the development and maintenance of program budgets aligned with the integrated project plans
  • Assist in the review of regulatory documents, SOPs, protocols and reports, where relevant
  • Work closely with senior management and functional area leads on ongoing enhancements and development of team processes, structures, and project reporting tools

Preferred Education and Experience:

  • PMP certification strongly preferred
  • Experience with US and EU regulatory filing requirements and processes, including end-of-phase 2 agency meetings, and NDA submissions, are strongly preferred
  • At least 5 years’ prior experience in program management for a clinical-stage drug development program required; oncology experience preferred
  • Small company, biotechnology experience strongly preferred
  • Managerial experience overseeing third party consultants and vendors in achieving corporate objectives
  • Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
  • Strong ability to proactively predict issues and solve problems, identify risks.

Qualities for Success:

  • Experience and passion to work with small teams
  • Ability to provide scenario analyses for appropriate decision making, post input from internal stakeholders
  • Strong ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
  • Excellent people (soft) skills, conflict resolution, diplomacy and positive influencing abilities
  • Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Microsoft Project, Visio, PowerPoint and Excel, etc.)
  • Presentation skills and poise in speaking in public settings
  • Strong capabilities in creating presentation materials in slide and written formats
  • Demonstrated record of being demanding of groups to meet timelines
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Strong critical, strategic, and analytical thinking 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.

Apply for This Position