Arrowhead Pharmaceuticals, Inc. is a Nasdaq listed (ARWR) company that develops medicines to treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead’s dynamic and innovative environment offers our employees the opportunity to advance revolutionary treatments for serious and intractable diseases. Our employees are smart, creative professionals who work collaboratively to meet our business and scientific challenges. Arrowhead’s R&D facility is located in the Research Park in Madison, WI.
The Program Manager will Initially assist senior program manager(s) in the management of one or multiple early and/or later-stage therapeutic development programs with a goal of rapidly assuming independent program leadership. S/He will have the overall responsibility for leading matrix-driven development teams with deliverables including, synthesis, integration and alignment of program strategy, planning and execution of strategy across disciplines. S/He will be the point person for Sr. Management regarding the planning, execution, timing, and risk assessment for assigned programs.
Key Duties and Responsibilities:
- Collaborate closely with the discovery, clinical, regulatory, CMC and toxicology team members and senior management, plus external partners to develop and maintain integrated program plans/timelines for the company programs including key commitments, deliverables, resources, and thereby ensuring projects are moving effectively toward their milestones and company goals.
- Apply project management best practices, including coordination and participation in project team meetings, development of meeting agendas, program timelines and budgets, streamlined and efficient meeting management, distribution of meeting summaries, and efficient follow up of all relevant action items
- Assist in the identification and timely resolution of program issues – including those related to timing, resources and funding, to prevent delays in program milestones. When required, step in to fill open gaps to keep programs moving forward effectively
- Interact effectively with other program managers and their teams to integrate timelines into a unified project/company timeline, identify and resolve crucial bottlenecks
- Track progress against program plans, generate regular status updates, and communicate progress and issues to management
- Work with functional area experts to plan clinical development strategies, draft research protocols, publications on Company research, and Target Product Profiles for Company development programs
- Support CRO/CMO/vendor selection and qualification
- Working knowledge of GMP, GLP, and/or GCP regulations, as well as ICH/FDA guidance documents.
- Excellent communication skills and ability to work with diverse professionals including all the functional areas involved with development of new therapeutics (e.g. toxicology and other IND enabling groups, clinical research, clinical operations, clinical supply, manufacturing, regulatory affairs, medical writing and more)
- Highly motivated team player willing to contribute to a growing biotech organization
- Strong MS Project, Excel, PowerPoint, and Word skills for Program Management
- Demonstrated capabilities and proven track record of problem solving during pre-clinical and clinical drug development a plus but not a requirement.
- Experience in one or more drug development functions, such as CMC, toxicology, drug discovery, assay generation, or clinical operations in a biotechnology, pharmaceutical or academic environment
- A track record in Program Management with preIND through proof-of-concept and later-stage development preferred
- Cardiovascular experience is a plus
- Ph.D. or other equivalent advanced degree in a biopharmaceutical-related area (e.g. biology, chemistry, toxicology, ADME/PK). M.S. in a biopharmaceutical-related area will be considered with balance drug development experience.
Physical or Other Requirements:
- Willingness and ability to travel as needed domestically and internationally to various business, clinical, R&D and manufacturing locations located throughout the world.
All applicants must have authorization to work for Arrowhead in the U.S.
Please send resumes to firstname.lastname@example.org. Include a cover letter that highlights your qualifications and matches our requirements.