Director/Senior Director, Early Development Strategic Operations

2 months ago

Remote, Oregon, United States Life Technologies (Thermo Fisher Scientific) Full time
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Division Specific Information

Our Early Development Services (EDS) team focuses on Phase I and IB trials which represent the first practical tests of a compound's clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound's efficacy, safety and positive impact on patient's lives.

Discover Impactful Work:

The Director/Senior Director, Early Development Strategic Ops will be an organizational leader with responsibility to support identification and implementation of operational strategies, processes and methodologies to optimize EDS delivery on behalf of key strategic clients. This leader will provide client-specific accountability for cross-disciplinary, EDS operational delivery against milestones & expectations.

A day in the Life:
  • Serves as EDS liaison to internal partnership personnel (VPSP, Development Operations, Biotech Portfolio Leadership (BPL)) in support of key strategic outsourcing relationships.
  • Serves as an advisor to the EDS project/program teams on operations-related issues to ensure application of key learnings and consistency across projects/programs and on strategic issues to ensure achievement of development program goals.
  • Communicates and coordinates with BPL/Dev Ops to identify and implement continuous process improvement opportunities relevant to EDS.
  • Supports EDS operational leadership for resourcing strategies to drive timely, quality and fiscally responsible delivery of all programs and projects placed with PPD.
  • Liaises with BPL/Dev Ops to ensure EDS is aligned with Sponsor's strategic, operational, and cultural priorities to optimize resources and exceed joint goals.
  • Assists the EDS operational leadership in training staff to fully enable alignment with the Sponsor's priorities.
  • Supports EDS partnerships within a strategic relationship for quality, risk management and compliance.
  • Works with BPL/Dev Ops lead to identify and track Key Performance Indicators and project performance metrics for EDS
Keys to Success:

Education
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years') or equivalent combination of education, training, & experience.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities
  • Proven leadership skills in a matrixed environment; proven ability to effectively influence executive/C suite team members relative to contribution to client deliverables
  • Comprehensive understanding of the clinical project management, the business organization and functional areas and business strategy
  • Excellent customer relationship management skills and strong commercial acumen
  • Ability to work in a high pressure/time sensitive environment including the ability to handle multiple issues on multiple projects simultaneously
  • Expertise in proposal development and demonstrated strategic planning skills
  • Strong organizational agility, negotiation skills, and demonstrated drive for results
  • Proven ability to build peer relationships and effective teams with demonstrated global and cultural awareness
  • Effective coaching, persuasion and mentoring skills
  • Excellent analytical skills, oral and written communications, strong attention to detail, prioritization and time management proficiencies
  • Comprehensive understanding of sponsor/CRO business practices and advanced knowledge of operational/financial practices, SOPs, GCPs, and FDA/ICH guidelines with the ability to analyze and evaluate processes and procedures
Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Ability to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • May require travel.
Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation

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