Senior Director, Technical Program Leader
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.
AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.
The Senior Director, Technical Program Leader provides leadership to the TPL organization and is responsible for CMC support for all Program Teams. This includes managing resources across programs plus partnering with governance boards and Program teams on CMC representation, objectives, deliverables, and business processes. The Senior Director will formulate and drive scientifical-ly sound and business driven technical Program strategy for all commercial and development programs, and ensure financial planning, risk assessments and contingency planning aligned with the overall program strategy and objectives.
- Lead the TPL organization and the Program Management team that supports TPLs. Ensures appropriate resourcing across programs. Provide guidance and direction to the team on escalated issues, partnering with the broader program teams to determine the best course of action.
- Partner with appropriate governance boards and overall Program teams on CMC representation, objectives, deliverables and other business processes.
- Define the commercial and development strategy and oversee the execution of CMC activities for programs within Avexis in line with line function and overall Program Team strategy.
- Represent Avexis Technical Operations as core member in the Program Teams for defining global technical strategy for development, submission, and approval in major markets of assigned product(s). Support teams with strong strategic focus, scientific and technical expertise, quality and regulatory awareness and management capabilities. Foster strong team spirit and promote knowledge exchange within and between teams.
- Represent CMC aspects of assigned programs in internal and external meetings (e.g. senior management boards, Health Authority meetings).
- Own the Technical Plan including risk assessments and contingency planning as appropriate and in line with overall Program Team project strategy and Avexis objectives. Ensure adherence to program governance and processes.
- Proactively communicate major changes to program strategy, key issues and any other critical topics in a timely manner to management, customers and stakeholders. Ensure that issues are resolved in a timely fashion and appropriately / non-unnecessarily escalated.
- Understand and pro-actively manage the cross-functional aspects of assigned program(s) among departments within and outside of Technical Operations (e.g. Regulatory, Safety, Clinical, Production, and Quality Control).
- Set the CMC sub-team(s) objectives in line with the Program Team objectives.
- Lead the CMC sub-team(s) in line with AveXis values and behaviors. Build strong team spirit and promote knowledge exchange within and between teams. Align priorities with team members.
- Support in-licensing / out-licensing opportunities as technical development lead.
- Proactively manage costs of assigned programs in compliance with business processes and targets. Assess, consolidate and negotiate timelines for assigned program(s) with relevant internal or external stakeholders and partners.
- Coach team members and contribute to their performance management / individual development as required.
- Ensure compliance of processes with external regulations as well as AveXis internal procedures.
- Actively participate in team activities and fulfill all related tasks and responsibilities related to own discipline.
- Proactively communicate key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant program team members.
- Give guidance to team members. Act as mentor for junior and senior associates as required. As required, monitor and report Key Performance Indicators (KPI) and performance, measures to enable strategic objectives are met or corrective action to be taken.
- Advanced degree in life science, engineering or equivalent.
- Minimum 13 years' experience in pharma/biopharma; a minimum of 5 years successfully demonstrated experience as a functional project leader.
- Thorough understanding of NBE drug development and commercialization, including knowledge of relevant internal and external regulations.
- Strong project management and organizational skills, team player, flexible and dedicated personality, demonstrated in cross-functional / international environment (matrix organization); proven track record of leading interdisciplinary and cross-cultural teams.
- Strong communication and presentation skills.
- Ability to coordinate a number of tasks simultaneously, prioritize and deliver against tight timelines.
- Proven record of accomplishment with innovation, creativity, problem solving attitude and productivity increase in development and / or marketed programs.
- Prior leadership experience. Advanced coaching and mentoring skills.
- Certification in Project Management is a plus.
The level of this position will be based on the final candidate's qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.