Associate Director / Director, Analytical Development

Overview

Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company's proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.

The Development team at Black Diamond Therapeutics is looking for a dynamic and self-motivated Associate Director / Director, Analytical Development to apply her/his expertise and knowledge to our drug development programs. Based in our office in Cambridge, MA, the right candidate will work closely with our CDMOs, lead analytical activities for both drug substance and drug product from pre-clinical through to NDA and commercialization.

Responsibilities

• Manage day-to-day analytical activities including timeline, budget management and objective setting
• As the technical expert, design detailed and phase appropriate work plans and execute the plans through partnership with our CDMOs. Guide CDMOs to conduct development, validation and testing. Technical oversight all the activities at CDMOs
• Lead phase appropriate analytical method development and validation from preclinical through to NDA filing in compliance with ICH and related guidances
• Lead phase appropriate stability studies for starting materials, intermediates, drug substance and drug product from preclinical through to NDA filing in compliance with ICH and related guidances. Stability assessment including OOC and OOT to establish shelf life.
• Lead development activities such as stability studies, compatibility studies, establishment of phase-appropriate specifications and control strategies for starting materials, intermediates, drug substance, excipients and drug product
• Lead the characterization of reference standards and analytical references, and manage the inventory
• Review and approve analytical results, protocols and reports
• Assist QC/QA with laboratory investigations, deviation investigation and review of investigation reports
• Author and review analytical development/validation reports and analytical sections in regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA etc.)
• Participate in the establishment of CQAs, specifications, IPCs for intermediates, drug substance and drug product
• Manage transferring analytical methods across CROs/CDMOs at all stages of drug development
• Lead the assessment and approval of GMP method change controls, investigation of OOS and OOT test results, and follow-up of corrective actions
• Review CMO/CRO SOPs, qualification protocols and validation protocols
• Collaborate effectively with the Project Management, Discovery, Quality, and Regulatory groups to meet program goals

Qualifications

• Requires an MS or PhD in analytical chemistry, organic chemistry or related field with 10+ years experience in analytical development in the pharmaceutical industry
• Small molecule API and solid oral dose form experience is required
• Demonstrate leadership skills, planning and organizational capabilities. Effectively implement work plans cross-functionally
• Proven ability to manage projects and work with cross-functional teams comprised of internal groups and external CDMOs
• Knowledge of analytical testing concepts and cGMPs including laboratory controls and good documentation practices across development stages from pre-IND to NDA
• Ability to work flexibly to accommodate program priorities, international activities, and travel as needed
• Demonstrated ability to build and maintain positive and collaborative relationships with management, peers and CDMOs
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
• Excellent oral and written communication skills
• Ability to work independently, or under minimal supervision to handle workflow in a multi-tasking environment
• Experience in CMC operations and project management considered a plus

Work Environment:

This job operates in a professional office environment with travel activities of approximately 20-30% of the time.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.

Black Diamond Therapeutics values our relationships with our Recruitment Partners and will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. Black Diamond is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Black Diamond who is not a member of the Human Resources team