Company Description

ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists authority, responsibility, and support to do cutting-edge work on therapies for treatment-resistant cancers. Our culture and values support our mission, provide a shared understanding of how we work together as a company and provide a clear sense of what is most important to us as an organization.

Reporting to the Chief Technical Officer (CTO), the Senior Director, Supply Chain will lead clinical supply chain team operations and commercial supply chain planning. This individual will lead the clinical supply chain team and manage end-to-end clinical supply activities for clinical stage programs and plan to commercialize late-stage assets. This position will design, develop, and implement clinical and commercial supply strategies to ensure appropriate continuous supply of material to patients. The successful candidate will work closely with Clinical Operations, Quality Assurance, Regulatory Affairs, and third-party CMOs and be responsible for all levels of studies, ranging from simple to complex and requires in-depth understanding of GMPs, global Health Authority requirements, project management, IRT, medication management and/or use of advanced simulation tools. Strong cross-functional team leadership and project management skills are essential requirements of the role.

Job Description

Responsibilities include and are not limited to the following:

• Develop comprehensive, strategic clinical and commercial supply chain plans and manage operational budgets. Establish streamline operations to reduce costs and improve overall supply chain performance.
• Manage external consultants and third-party vendors, including collaborating with QA on vendor selection and quality and supplier agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
• Interpret clinical trial drug requests and protocols and develop clinical packaging strategies, timelines, and budgets.
• Responsible for scheduling and delivery of clinical supplies, including creating label and packaging design, subject randomization, packaging, labelling and distribution of clinical supplies.
• Responsible for establishing a cost-effective and efficient commercial labeling and distribution system, including product serialization and tracking. Contribute to IRT system design for areas related to drug supply management and participate in related system activities from user acceptance testing to archival.
• Coordinate primary and secondary packaging, labeling, testing, distribution and return drug management activities with CMO’s.
• Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies, workflows, and priorities in response to changing business needs, technologies, and stakeholder expectations.
• Operate closely with logistics function to proactively plan, document, and facilitate global cross border distribution strategies.
• Interface with QA, RA, CMC/manufacturing to ensure trial supplies are appropriately supported including shelf life, quantities, country approvals and specification.
• Develop and manage forecasting and ordering investigational product, commercial and comparator material in global trials.
• Proactively find solutions to emerging issues in an effective manner while taking into consideration risks and cost-effectiveness.
• Independently create clinical supply study budgets and monitor spend to-date compared to the approved study budget.
• Develop new functional SOPs, Policies/Plans as necessary.
• Exhibit leadership capabilities to manage and develop Clinical Supply Managers of all experience levels by aligning team goals with organizational objectives.

Qualifications

Required Qualifications:

• 15+ years of relevant experience in clinical and commercial supply chain management in the pharmaceutical industry with an MA/MBA or equivalent desired.
• Proficiency in ICH, GMP, and regulatory guidance important to new drug development and commercialization. Experience with commercial products and regulatory interactions preferred.
• Demonstrated success in working with and managing CDMOs and external partners using succinct and thorough communication skills.
• Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work.
• Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met.
• Results driven, collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks
• Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations, including with senior executives

Additional Information

The anticipated salary range for candidates who will work in our South San Francisco location is between $240,000-$290,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.