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Sr. Project Director, Evidence Development Solutions - Oncology

Role overview

Qualifications

  • Bachelor's degree in Life Sciences, Healthcare, or Business or equivalent industry experience
  • Minimum 15-20 years of clinical research operations experience
  • Minimum 8 years supervisory/management experience
  • Proven understanding of operational clinical operations and overall drug development processes

Responsibilities

  • Provide strategic leadership and support to project teams
  • Lead and mentor multidisciplinary project teams
  • Monitor delivery of projects and ensure compliance with budgets
  • Serve as the senior operational contact with clients for all project-related items

Key facts

Other skills

  • Quality Control
  • Creative Problem Solving
  • Communication
  • Teamwork
  • Time Management
  • Decision Making

About the company

UBC logo

UBC

Pharmaceuticals

Dedicated to Global Product Safety, Brand Loyalty, and Patient Access Strategies that Support the Full Product Lifecycle United BioSource LLC (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our diverse suite of services helps bridge the gap between development and delivery and builds brand loyalty through patient access and adherence. UBC is well known for our ability to generate authoritative, real-world evidence of product effectiveness, safety, and value to assist healthcare decisions and enhance patient care. Developing a drug, taking it through commercialization, and demonstrating its post-launch value and safety is a complex journey. Regulatory hurdles and payer decision-making are increasing the complexity around drug development and product choices. UBC has aligned our expertise and industry insight to help manufacturers make informed decisions early in the product journey that ultimately optimize care and improve patient outcomes. The most successful product journeys start with great maps. UBC’s industry-leading experts work in unison to effectively navigate the product lifecycle, focusing on: Clinical Development Safety Commercialization We understand what it takes to compete in a crowded product market with many stakeholders that demand the right evidence at the right time. Our Past, Present, and Our Future UBC was founded in 2003 by industry experts with a passion for innovation and a commitment to working with pharmaceutical and biotech organizations in proving the safety, efficacy, and value of pharmaceutical and medical products. We recognized the opportunity to build an organization tailored to meet the need for scientific evidence in the healthcare industry. And, we quickly developed our core strength – the generation, analysis, and communication of real-world evidence throughout the product lifecycle.

Company details

Company typeLarge
IndustryPharmaceuticals
Company size1001 - 5000

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Job description

As leaders in the pharmaceutical support industry, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation. 

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC! 


NOTE: This position requires strong experience in Oncology and Biotech.


Brief Description:  

The Sr. Project Director (PD) is responsible for engaging and delivering activities related to project operations, financial performance, business development, and department administration within the UBC Evidence Development Solutions Department. 

The Sr. PD is responsible for providing senior operational leadership, oversight, and client relationship management for a broad range of UBC projects and programs. The Sr. PD will have a leading role in overseeing the planning, implementation, direction, and completion of project work. The Sr. PD will be responsible for directing Project Managers and cross-functional teams to ensure satisfactory delivery of contracted services within the allocated timelines, budgets, and quality standards. Additionally, the Sr. PD will lead and direct business development opportunities, conduct line management of Project Associates, Associate Project Managers, Project Managers, Associate Project Directors as required, and participate/lead departmental process initiatives.

Specific job duties:

  • Project Leadership: 
    1. Provide strategic leadership, vision, and support to the project teams, ensuring alignment with the company's goals and client expectations. 
    2. Drive PM performance, project quality delivery, milestone timeline adherence, financial margin optimization, and customer satisfaction through efficient and effective directorship. 
    3. Ensure project teams prepare project plans to meet contracted services and timelines.
    4. Engage in UBC cross-functional interactions to address project needs and drive problem resolution; facilitate the involvement of Senior Management as necessary
    5. Attend/participate in project internal / external meetings, and audits as needed 
  • Project Team Productivity: 
    1. Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, ensuring effective communication, collaboration, and performance of project deliverables according to contract terms. 
    2. Work with cross-functional managers to ensure projects are adequately staffed team members receive adequate training for specific job assignments.
    3. Vendor Management: Select, contract, and manage external vendors and subcontractors, when necessary, while maintaining quality and cost-effectiveness.
  • Financial Oversight: 
    1. Monitor delivery of projects per scope and budgets, and demonstrate strong oversight of financial health for assigned projects
    2. Oversee project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications.
  • Risk Management: 
    1. Proactive, ongoing identification of project risks and development of mitigating strategies to minimize their impact on projects effectively.
    2. Ensure development and maintenance of risk management plans and risk assessments and categorization tools.
  • Client Relationship Management: 
    1. Serve as the UBC senior operational contact with clients for all project related items, maintaining strong relationships, addressing their needs, and providing regular project updates. 
    2. Ensure regular conduct of formal governance discussions to assess performance and drive issue resolution. 
  • Quality Compliance Oversight:
    1. Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance.
    2. Ensure activities on projects are delivered with adherence to project Plans, company policies and/or sponsor’s SOPs.
    3. Be familiar with and ensure that all projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA).
  • Reporting: 
    1. Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior management.
    2. Ensure that project specific tracking metrics are developed, consistent with scope of work and project timelines. 
    3. Ongoing review of available dashboards and reports for assigned projects to ensure adherence to all required activities and operational / financial performance indicators
  • Business Development: 
    1. Lead and drive specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation.
    2. Work with UBC Business Development to develop and grow UBC client relationships and maximum business opportunities.
    3. Attend and present at conferences as required.
  • Department Administration
    1. Responsible for the development, implementation, and project management process compliance for global projects 
    2. Lead, innovate, and develop operational strategies that meet requirements and maximize project delivery success.
    3. Identify, develop, and implement improvements to UBC processes, quality, and overall project delivery
    4. Engage in cross-functional collaborations with UBC leadership staff to optimize project delivery
    5. Contribute to UBC meetings, training activities, and cross-functional activities as appropriate
    6. Responsible for leading ongoing assessment of project delivery resource needs, including management of resource requests and oversight of department allocations aligned to utilization targets. 
    7. Implement creative resourcing solutions to maximize productivity and utilization of the team.
    8. Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources.
    9. Identify and develop UBC process improvements 
    10. Prepare procedures, SOPs, guidelines and other standard materials for department
    11. Ensure staff are adequately trained on applicable SOPs, processes, and systems
    12. Ensure timely completion of timesheets and expense reporting by assigned staff
    13. Ensure timely completion of required UBC and project specific training by assigned staff
    14. Other duties as assigned by UBC Senior Leadership

 

Expected Project Load:

    • PD Oversight of 6 to 8 projects, depending on scope
  1. PD Oversight of up to 2 multi-study programs, depending on scope

 

Supervisory Responsibility:  

  • Mentor, provide support, and direct supervision of Project Managers, Associate Project Managers, Project Associates, and other administrative staff. 
  • Conduct interviews for internal/external project management and operational candidates
  • Conduct ongoing performance review of assigned staff and remediate deficiencies
  • Conduct annual employee performance evaluations

Desired Skills and Qualifications:

  • Bachelor's degree in in an appropriate discipline (Life Sciences, Healthcare, or Business) or equivalent industry experience. Advanced degree (Master's or Ph.D.) preferred.
  • Minimum 15-20 years of clinical research operations experience, within in a CRO, pharmaceutical, device/diagnostics or biotechnology company
  • Minimum 15 years of experience at increasing levels of project management or clinical research oversight responsibilities 
  • Previous history as a Project Director or Director of Clinical Operations (related) within a CRO preferred
  • Minimum 8 years supervisory/management experience
  • Proven ability to lead, motivate, and manage cross-functional teams.
  • Deep understanding and experience in operational clinical operations and overall drug/biologic development processes
  • Strong knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and medical writing)
  • Comprehensive knowledge of ICH GCP and applicable international regulations (EU Clinical Trials Directives, FDA Guidelines, etc.)
  • Broad therapeutic experience a plus
  • Proven understanding of methodological, scientific, and operational aspects related to the planning and execution of evidence development and RWE programs (e.g., Phase IV studies, RWE, Ph II – III clinical trials, expanded access programs, etc.) globally
  • Ability to drive operational strategy for global evidence development programs
  • Experience in pricing/proposal models for evidence development programs and application to staffing requirements.
  • Client focused with enhanced leadership skills
  • Excellent verbal, written, and interpersonal communication skills
  • Excellent prioritization, time management, and project management skills
  • Excellent negotiation, influencing, consensus building, and relationship management skills
  • Excellent innovative, analytical, problem-solving and decision-making skills
  • Excellent financial acumen and budget management experience.
  • Excellent computer skills including MS Office
  • Proficiency in project management tools and software
  • Results driven and team-oriented, with the ability to influence outcomes as necessary
  • Demonstrated ability to manage staff to achieve company and client goals
  • Ability to handle multiple tasks in a fast-paced, deadline oriented environment
  • 10% travel availability

 

UBC Benefits:

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally. Here are some of the exciting perks UBC offers:

  • Remote opportunities
  • Competitive salaries
  • Growth opportunities for promotion
  • 401K with company match
  • Tuition reimbursement (after 90 days of employment)
  • Flexible work environment
  • Discretionary PTO (Paid Time Off)
  • Paid Holidays
  • Employee assistance programs 
  • Medical, Dental, and vision coverage
  • HSA/FSA
  • Telemedicine (Virtual doctor appointments)
  • Wellness program
  • Adoption assistance
  • Short-term disability (after 90 days of employment)
  • Long-term disability
  • Life insurance
  • Discount programs


UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, or basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable, and inclusive culture that fosters respect for each other, our clients, and our patients.


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