Senior Director, Head of Process Chemistry
Description
ORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients’ lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking a highly motivated process development and chemistry leader with a proven record of sustained laboratory achievement and innovation to join our growing Pharmaceutical Sciences (Pharm Sci) group at ORIC Pharmaceuticals, responsible for Chemistry, Manufacturing, and Controls (CMC) for all our assets. The successful candidate will report to the Head of Pharmaceutical Sciences and will be responsible for the following.
Essential Functions:
• Technical, budgetary, and development oversight of Process Chemistry, including all outsourced and in-house activities to ensure deliverables are timely, robust, and adequately derisked across various time horizons.
• As part of the Pharmaceutical Sciences Leadership Team, conceptualize, initiate, and oversee the plans and execution of deliverables required for overall success of our portfolio with a vision towards building value for ORIC and patients.
• Build and align Process Chemistry and CMC strategy and deliverables in alignment with corporate and cross-functional goals, to move programs forward.
• Ensure uninterrupted clinical supply at all times.
• Function as Pharmaceutical Development Team Lead and CMC representative on Development Team for a program on registrational path, ensuring coordination, seamless communication, and execution across different departments and functions by building and nurturing close, trusting relationships, frequent interaction, and oversight of key deliverables. These functions within CMC include Process Chemistry, Analytical Sciences, Formulation and Drug Delivery, Project Management, and Clinical Supply Forecasting and Management. Key functions outside CMC include Quality, Regulatory, Clinical, Safety, Corporate Program Management, Project Team Leaders, Toxicology, DMPK, Preclinical functions, Budgeting and Forecasting, IP, and others as organization evolves.
• Create and execute plans for projects required to move programs forward by providing technical guidance, strategic and tactical direction, and oversight to ensure all the requirements are designed and delivered appropriately and in a timely manner for all the stakeholders and customers.
• Author and review technical reports, technical packages, relevant sections in health authority filings (including INDs, NDAs, annual reports, and any other regulatory interactions), and contribute to regulatory filing strategy. Ensure all development work is fully captured in technical reports, tech transfer and cGMP production records with process development and characterization conducted consistent with QbD principles, risk assessments as needed, and process validation as appropriate and in compliance with regulatory expectations.
• Prepare presentation materials and clearly communicate progress to manager in real time/weekly, as appropriate, and at internal/external meetings, as needed.
Requirements:
• PhD in organic chemistry or relevant pharmaceutical sciences with 15+ years of relevant hands on pharmaceutical/biotech industry experience, or equivalent, in the field of new drug discovery and development.
• Demonstrated technical and strategic leadership experience with accountability for managing a team of process chemists with a track record of being an effective leader and manager as demonstrated by lab management, hiring, and mentoring direct reports. Able to work as part of a team with strong interpersonal skills.
• Proven track record of problem solving.
• Scientific excellence as demonstrated by publications, presentations, and leadership/engagement in the scientific/professional community.
• Clear and practical understanding of all process chemistry and analytical tools (equipment, work packages, and processes), reaction safety hazards assessment, reaction design and scaleup, process characterization, technology transfer validation, statistical methods, and working in GMP environment.
• Awareness and practical understanding of ICH, GMP, and regulatory guidances that are important to consider in new drug product development.
• Experience in writing and reviewing batch records, specifications, stability protocols/data review, and development reports.
• Experience in late-stage drug development, including putting together data and documents towards, authoring/reviewing, and submitting an NDA for a small molecule commercial product highly preferred.
• Demonstrated ability to work efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes internal and external partners, such as CROs, CMOs, and CDMOs.
• Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met, as external environment and stakeholder input evolves. Brings project management skills to anticipate and manage internal and external resource needs, including finances, people, skills, information/technical deliverables, and time.
• Excellent oral and written communication skills. Succinct, complete, and convincing communication with attention to detail, reflecting analytical and critical thinking – adjusting one’s communication style appropriate for the audience; and being timely and effective in communications with senior management and direct reports.
• Self-aware leadership in a feedback rich environment reflected in the pursuit of constant development, growth, and improvement for self and others. Builds an inclusive and welcoming team environment where everyone feels invited to speak up and contribute to their best abilities.
• Excellence in time management and prioritization skills to balance various project and department deliverables.
• Job is onsite in South San Francisco, California. Hybrid work arrangement negotiable. Level is commensurate with experience.
The anticipated salary range for candidates who will work in our South San Francisco location is between $245,000- $304,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.