Senior VP, Strategic Solutions and Patient Centricity, Oncology
ERGOMED
Executive Director, Lifecycle Lead
Kyverna Therapeutics
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $270,000 - $310,000 per year
Job Level
Senior
About the role
- Manage one or more development programs (KYV-101 and KYV-102) by leading multidisciplinary/cross-functional teams.
- Lead definition and delivery of integrated asset strategy throughout the lifecycle maximizing asset/program value consistent with corporate & portfolio strategy.
- Lead the program and program team to achieve objectives in accordance with quality standards and timelines validated with governance.
- Ensure oversight of the Program budget in partnership with functional heads accountable for delivery within budget.
- Ensure program activities are conducted within the agreed asset strategy framework and overall strategic objectives of the Company.
- Ensure cross-functional alignment with Research, non-clinical & clinical, Manufacturing & Commercial, IP, communication, quality (compliance) representatives.
- Ensure compliance with external regulations and good project management practices.
- Validate planning and implementation via governance and reporting according to company processes.
- Own the integrated strategy and ensure validation of the integrated development plan by key stakeholders and external experts/customers.
- Ensure cross-functional engagement and full team alignment to execute program strategy.
- Assess opportunities and risks with key function leaders and develop mitigation plans and backup scenarios.
- Establish "go/no go" decision points and present to Governance meetings; develop and recommend strategic options to governance.
- Manage internal and external communications for the Program, represent company internally and externally (congress, partnering, negotiation).
- Define and implement program internal & external communication plans and ensure consistency of external messages.
- Own all Program Documents required by Governance, Quality, Compliance & PMO guidance.
- Deliver key program outputs: integrated cross-functional development strategy and plan, status updates/dashboards, risk/opportunity logs and mitigation plans, key decision point documentation.
- Contribute to functional project documentation and deliverables (Clinical trial documents, IND file, investigator's brochure, Briefing Documents, scientific publications, collaborations, CDMO decision documentation, HA interaction materials).
Requirements
- PhD or equivalent degree and 10+ years in pharmaceutical industry as a program/LCL lead.
- Proven experience in the field of biologics and autoimmune/oncology/hematology. A thorough knowledge of the pharmaceutical business model, of the value chain, especially in a Health Care environment.
- Experience of working with research, clinical & non-clinical development or commercial collaborations with alliance partners.
- Demonstrated Drug Development knowledge with understanding of the cross functional nature of the role including: Research, Translational Sciences, Clinical, Manufacturing, Commercial and Regulatory.
- Strong command of clinical data and able to interpret complex data packets
- Experience with NDA, BLA filings and regulatory submissions for different parts of a lifecycle both early and late.
- Experience of working in an international environment.
- Demonstrated ability to drive initiatives, solve issues, pre-empt problems and achieve objectives.
- Ability to multitask and promote objective deliverables in resource constraint environment.
- Experience in cross-functional drug development and clinical-stage program management.
- Understanding of the drivers of commercial success and the interplay between all customers, patients, physicians, pathologists/regulators payers etc.
- Ability to work effectively and manage stakeholders in a smooth & efficient way.
- Ability to drive delivery and advance complex global programs despite potentially adverse and changing conditions through effective governance and targeted executive escalation in a matrix organizational set up.
- Experience and ability to innovate and guide the team to think and deliver creatively in order to generate value.
- Demonstrated expert judgment with the ability to quickly identify, analyze, evaluate, escalate and/or resolve problems, which could negatively impact global program implementation and/or financial results.
- Excellent interpersonal and communication skills (verbal and written) with the ability to communicate and motivate with a persuasive, credible presentation style.
- Ability to resolve issues/ conflict in a constructive manner.
- Ability to develop bold ideas and take calculated risks.
- Strong tolerance for ambiguity, agility to adapt to change, confidence to speak-up and challenge appropriately.
