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Senior Drug Development Director - Home-Based (East Coast)

  1. Canada, United States
2024-113396
  1. Project Management
  2. ICON Strategic Solutions
  3. Remote

About the role

In this organization, a distinction is made between project teams that drive asset strategy development and execution and those focused on indication strategy development within the established frameworks. Early Development Strategy Teams concentrate on asset development until a decision is made to enter Clinical Phase 2A, or proof of concept in patients. After this phase, teams are designated as Asset Strategy Teams. Clinical Development Teams (CDTs) focus on specific clinical indications and may share subject matter expert leads across different CDTs within a medical specialty. Once a CDT begins to launch an indication into the market, it is referred to as the Indication Development Team, with a shift in leadership focus from clinical operations to a more commercial orientation.

 

The Drug Development Project Manager (Senior Drug Development Director) oversees the high-level plans and progress of these teams, managing projects from pre-clinical stages through to commercialization. The DDPM is responsible for incorporating overarching indication activities and milestones, documenting their downstream impact, and justifying changes in project budget and resources. This role involves close collaboration with the Asset Strategy Lead and function leads within the EDST or AST. The DDPM compiles and owns the integrated cross-functional project plan, ensuring alignment with corporate strategy.

 

As part of the Project Management Office (PMO), DDPMs advocate for project management techniques and processes, coaching team members on consistent utilization, including risk mapping, mitigation strategies, and logging lessons learned.


  • When in a managerial role, the DDPM supports the development of team members, enhancing their confidence, skills, and experiences in alignment with corporate strategy while ensuring the team adheres to agreed project scopes.
  • Establishes a project lifetime plan with appropriate detail, proactively identifying risks and resolving issues.
  • Maintains and communicates project timelines, budgets, and resource allocations, flagging delays and discrepancies while liaising with governance, finance, and function heads.
  • Fosters high team performance by proactively engaging stakeholders and partnering with project leadership to ensure effective governance meetings.
  • Collaborates with various teams and function leads to translate strategies into integrated project plans, taking ownership of these plans and sharing insights that influence project direction.
  • Encourages positive team dynamics, working with HR to organize team-building activities and ensuring secure document sharing among team members and stakeholders.
  • Communicates any significant project accelerations or delays to leadership, driving corrective actions as needed.
  • Partners with internal and external stakeholders to establish effective project communications and manage changes towards common goals while promoting conflict resolution.
  • Develops and implements methods and frameworks for quality decision-making to support operational excellence in drug development projects and process improvement initiatives.
  • Collaborates with finance to address budget-related inquiries, conduct baseline comparisons, and perform variance analysis, optimizing internal project templates.
  • Co-creates dashboards with business process managers and acts as a liaison to identify reporting needs from business partners.

  • Strong leadership skills, promoting values that enhance team dynamics.
  • Excellent communication skills, fostering inclusivity and collaboration.
  • Proven interpersonal skills for conflict mediation and management.
  • Solid project management skills with broad exposure to the pharmaceutical R&D process; advanced planning experience with MS Project is essential. PMP certification is a plus.
  • Adaptability to continuous change.
  • Proficient verbal and written English communication skills (full professional proficiency required).
  • Advanced degree (Master’s or PhD) in a health-related discipline or equivalent experience.
  • Minimum of 10 years of experience in drug development across various phases and disease areas.
  • At least 5 years of program management experience in a pharmaceutical or biotech setting, preferably in cross-cultural environments.
  • Genuine interest and some experience in people management.
  • Experience in Regulatory Affairs and/or Clinical Development is an advantage.


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

 

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**

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