This position is created for a clinical development physician to serve as a medical monitor and/or lead programs in Oncology. The primary activity will be the Zanidatamab breast cancer program, but the position is not necessarily limited to it. This person will be responsible for leading a team that oversees the development of clinical studies (both global and US), the interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory and business development, and with external stakeholders including regulatory agencies and thought leaders (advisory boards, etc). The lead may oversee collaborations with partner companies to oversee the joint development of multiple products. In addition, the lead will contribute to the overall Jazz strategy in Oncology and contribute to due diligence activities that will lead to additional assets brought into the Therapeutic Area. The position will require a deep understanding of hematology-oncology drug development and relevant clinical experience in the therapeutic area.

• Lead Hematology Oncology Clinical Development Product Team and Lead cross-functional strategy for development of Oncology products
• Develop and implement strategic clinical plans in alignment with goals for thHematology Oncology Therapeutic area.
• Set clinical development plan for lead asset(s).
• Contribute to clinical development strategy for hematologic and solid tumors.
• Work within a matrix Research and Development organization
• Devise executive strategy to develop and implement clinical studies for investigational medicines and new indications for approved medicines
• Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical, external partners,pharmacovigilance/drug safety) to facilitate the execution of clinical trials and programs
• Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management
• Provide clinical/scientific input during the development, execution and completion of
• clinical trials
• Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areas
• Review and support prioritization of Investigator Sponsored Trials
• Serve as lead medical representative with regulatory agencies
• Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
• Work with medical affairs on KOL mapping, publication planning
• Work with DM on planning for data extractions in support of clinical data
• Lead the development and implementation of communication/education programs designed to effectively communicate the therapeutic area to key opinion leaders, investigators and physicians
• Lead clinical advisory board meetings to obtain strategic input into clinical program
• Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
• Partner with corporate development on the identification of external assets to build and strengthen the therapeutic area
• Provide clinical expertise and strategic input on new product concepts, long-range strategic plans and licensing opportunities
• Provide leadership to the multidisciplinary team and may manage other members of the clinical development team