Job Description:The Director, Program Management's primary responsibility will be to oversee across all functions, the successful execution of clinical asset development activities. This is a highly visible leadership position within the organization which requires ensuring and enabling alignment with corporate strategic goals, timelines, and budget constraints.
Essential Responsibilities:- Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability.
- Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner.
- Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
- Partnered with an MD, lead one or more cross-functional clinical candidate development program teams comprised of representatives from Clinical Development, Clinical Operations, CMC, Nonclinical, Regulatory, and Bioanalysis.
- Serve as a key liaison between program teams and executive leadership, delivering critical updates, strategic recommendations, and facilitating governance interactions.
- Establish, maintain and enforce best practices in program management, knowledge sharing, and operational excellence
- Timely revenue management and forecasting; high level capacity forecasting to support incoming business planning.
- Understand and manage cross-functional tasks and timeline dependencies, including critical path activities and resource constraints.
- Proactively identify risks to successful program execution and develop/implement requisite risk mitigation strategies and tactics.
- Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience.
- Maintain all appropriate corporate standards for facility safety and hazardous material management.
- Other duties as assigned.
Essential Physical Characteristics:Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
On-Site Protocol:Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
Qualifications:
- MS or PhD in Biology, Chemistry, Pharmaceutical Sciences, or related field of study.
- Project management with 8+ years of relevant experience in the pharmaceutical industry.
- Must be well-versed in the various stages of pharmaceutical development, with a special emphasis upon regulatory agency expectations as defined in ICH guidance documents.
- Demonstrated experience in building project management tools/templates, improving project systems and implementing best practices.
- Proven track record in managing programs from early development and through late-stage clinical milestones, including regulatory submissions.
- Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role.
- Proficient in the use of project management tools (e.g., Smartsheet or MS Project).
Required Key Attributes:- Must be able to work independently with supervision as needed.
- Proficient at working well in cross-functional team settings
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
- Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment.
- Strong problem-solving skills and a proactive attitude towards exploring new approaches.
- Exceptional understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
