Director, Technical Program Lead

Location
Libertyville, IL, US
Posted
Oct 10, 2020
Ref
5512
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Director, Technical Program Lead (TPL) formulates and drives scientifically sound and business driven technical Program strategy for all assigned commercial and development programs, including financial planning, risk assessments and contingency planning as appropriate and in line with the overall program strategy and objectives. The TPL leads, represents, manages and supports the Novartis Gene Therapies (GTx) CMC Program Team ensuring alignment with other departments and functions inside and outside of as well as third parties as appropriate.The Director, Technical Program Lead (TPL) formulates and drives scientifically sound and business driven technical Program strategy for all assigned commercial and development pro-grams, including financial planning, risk assessments and contingency planning as appropri-ate and in line with the overall program strategy and objectives.The TPL leads, represents, manages and supports the GTx CMC Program Team ensuring alignment with other departments and functions inside and outside of as well as third parties as appropriate.

Responsibilities

 

  • Define the commercial and development strategy and lead the execution of CMC activities for assigned programs within GTx in line with line function and overall Program Team strategy.
  • Represent GTx 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 GTx 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, 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 GTx 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 GTx 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.
  • Actively contribute to team goals.
  • As required, monitor and report Key Performance Indicators (KPI) and performance measures to enable strategic objectives are met or corrective action to be taken.


Qualifications

 

 

  • Advanced degree in life science, engineering or equivalent.
  • Minimum 10 years' experience in pharma/biopharma; a minimum of 3 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.
  • 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.

Novartis Gene Therapies 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.

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