Clinical Program Manager

Haya Therapeutics SA; Schweiz; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

The Clinical Program Manager at HAYA Therapeutics acts as the central contact for a program, enabling seamless transition from nomination through clinical phases to ensure timely, budget-conscious, high-quality delivery of assets.

It coordinates cross-functional activities across clinical, nonclinical, biomarkers, CMC, regulatory, and quality to align milestones, plans, and risk mitigation for on-target execution.

Qualifikationen

• Proven clinical program management experience across early development to clinical phases.
• Demonstrated capability in global drug development planning and timeline remediation.
• Financial forecasting, budget tracking, and management of CRO milestones.
• Analytical problem solving with robust ADR (Actions, Decisions, Risks) logs.
• Proficiency in MS Project, Excel, PowerPoint, and Outlook for cross-functional coordination.

Aufgaben

• Lead cross-functional program activities across clinical, nonclinical, biomarkers, CMC, regulatory and quality to ensure synchronized progression.
• Consolidate integrated program timelines and operational plans to proactively resolve bottlenecks and maintain on-target execution of milestones.
• Coordinate supply schedules and data deliverables to ensure timely availability of trial materials and safety profiles.
• Incorporate regulatory and quality assurance guidance to maintain compliance throughout the development lifecycle.
• Manage program scope, monthly forecasts, and budget changes with variance tracking.
• Maintain ADR logs to enable proactive issue mitigation and leadership visibility.

Kenntnisse

Cross-functional collaboration

Risk management

Data reporting

Financial analysis

Vendor management

Regulatory knowledge

Tools

MS Project

Excel

PowerPoint

Outlook

Jobbeschreibung

At HAYA Therapeutics, we are revolutionizing RNA-guided genome-targeting therapies to treat fibrosis, heart failure, and other serious diseases associated with aging. Our innovative platform leverages long non-coding RNAs (lncRNAs)—key regulators within the “dark matter” of the genome to develop first-in-class, highly specific therapies that modulate gene expression and restore cellular function.

Recognized for our innovation, HAYA received the prestigious Innosuisse Certificate for Sustainable Growth and has been nominated as TOP Innovative Companies in Switzerland 2025. As a fast-growing biotech, we offer an entrepreneurial, science-driven environment where you’ll have a direct impact on shaping our pipeline and advancing RNA medicine.

Purpose:

The Clinical Program Manager acts as a central contact for information on a particular program and enables the seamless transition and execution of clinical development programs from DC nomination through clinical phases to ensure the timely, budget-compliant, and high-quality delivery of therapeutic assets.

Accountabilities

• Lead cross-functional program activities and communications across clinical, nonclinical, biomarkers, CMC, regulatory, and quality departments to ensure the synchronized progression and delivery of clinical development programs.
• Consolidate integrated program timelines and operational plans across all contributing disciplines to proactively resolve bottlenecks and maintain on-target execution of key milestones.
• Coordinate critical supply schedules and data deliverables from CMC and nonclinical teams to guarantee the timely availability of clinical trial materials and supporting safety profiles for active studies.
• Integrate strategic guidance and documentation reviews from regulatory and quality assurance functions to maintain strict compliance with global health authority standards throughout the development lifecycle.
• Manage program scope, monthly forecasts, and financial changes through active variance tracking to ensure strict adherence to overall clinical trial budgets.
• Maintain comprehensive program information and the actions, decisions, and risks (ADR) log to facilitate proactive mitigation strategies, resolve escalating issues, and ensure accurate visibility for senior leadership.

Required Knowledge and Experience

• Clinical Development & Regulatory Expertise: Proven technical proficiency in guiding early-stage therapeutic assets through Investigational New Drug (IND) transitions into active clinical development, supported by a thorough understanding of each functional area’s role and contribution to the development process
• Operational Planning & Execution: Demonstrated capability in clinical program management, with in-depth knowledge of developing integrated global drug development plans, executing timeline remediation, and proactively resolving cross-functional bottlenecks.
• Financial & Vendor Management: Functional expertise in strategic budget assessment, monthly financial forecasting, variance tracking, and monitoring complex clinical trial budgets and CRO milestones.
• Risk Mitigation & Documentation: Capability in analytical problem-solving and maintaining robust program documentation, specifically actions, decisions, and risks (ADR) logs, to drive proactive mitigation strategies and ensure data visibility for leadership.
• Communication & Systems Proficiency: Excellent interpersonal, communication, and negotiation skills essential for aligning cross-functional teams, coupled with solid technical proficiency in MS Project, Excel, PowerPoint, and Outlook.

Leadership Profile

The successful candidate will demonstrate:

• Exceptional analytical acumen focused on delivering accurate, comprehensive data reporting to global organizational stakeholders.
• Proactive risk-management capabilities, consistently identifying and escalating critical timeline or budget issues without compromising program integrity.
• Strong collaborative leadership, seamlessly aligning cross-functional teams toward the unified execution of strategic clinical goals.

HAYA Therapeutics is an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace where all individuals feel valued and empowered. We provide equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, or gender expression), national origin, ancestry, age, marital or familial status, veteran status, disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

We prohibit discrimination and harassment of any kind and are committed to ensuring fair and equitable treatment in all aspects of recruitment, hiring, promotion, compensation, benefits, training, and career development.

At HAYA, we believe that diversity of thought, experience, and background drives innovation and strengthens our mission to transform patient care through cutting-edge RNA-based therapeutics.