Sr. Director/Director Chemical Development

Senior Director or Director of Chemical Development

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Oncology Inc is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options.  Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

The Senior Director or Director of Chemical Development will lead the late-stage process development activities for Rain’s lead program.  The successful candidate will direct and oversee contract development and manufacturing organizations (CDMOs) as well as lead process development efforts in preparation for successful process validation (PPQ), NDA/MAA submissions as well as commercial launch.  

Key Requirements:

• Lead and manage CDMO activities for late-stage development (e.g., tech transfer, scale-up/process development/optimization and from process validation through commercialization).
• Expert knowledge and experience in leading process development studies according to the principals of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identify proven acceptable ranges (PARS) of critical process parameters (CPP), including identification of edge-of-failure (EoF), Process Failure Mode and Effects Analysis (FMEA), and characterization of APIs to identify critical quality attributes (CQA).
• Review of quality control testing and certification that batches meet specifications and are in compliance with cGMP; and document and institutionalize all development activities as source materials for regulatory filings.
• Author and review validation related documents and process development reports.
• Lead NDA readiness activities and contribute to writing key CMC sections of regulatory documents of IND/IMPD/NDA/MAA.
• Successfully lead chemical development teams in a CMC matrix environment (AD, QC, QA, DP & regulatory).
• Drive continuous improvements in the drug substance development process through technological innovation and problem solving.
• Serve as subject matter expert in drug substances and help drive best practices and technical advancements.
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Design chemical development strategy that is phase-appropriate and well positioned for accelerated development, and design and execution of validation master plan to support commercialization.
• Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive) is applied for CMC development strategy and effectively communicate to functional groups across all levels of the organization and competent authorities.

Preferred Education and Experience:

• PhD or MS in Organic Chemistry preferred, Chemical Engineering (or related discipline) with 12+ years of experience (15+ years of experience with MS) in the Pharmaceutical or Biotech industry. 
• The successful candidate will have a demonstrated track record chemical development of multiple small molecule programs through process validation (PPQ), marketing applications and commercial launch in US and EU.
• Well-versed and demonstrated success in the application of QbD principles.
• Demonstrated success in shepherding late phase drug substance characterization through validation, pre-approval inspection and commercial manufacturing.
• Extensive experience in managing contract manufacturing organizations in North America, Europe and Asia.
• Have strong organizational, communication and planning skills to determine appropriate resources for resolution of problems.
• Ability to travel domestically and internationally up 25% of the time.

The pay range that the Company reasonably expects to pay for this position at the Director level is is $212,000 - $243,000 and at the Sr. Director level is $242,000 - $292,000; the pay ultimately offered may vary based on objective considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of financial, health and wellness benefits, dependent on the position offered.

Rain Oncology Inc 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.