Experience Inc. Jobs

Who is PPD?

PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Position summary:

• Responsible for the operational planning, management and operational excellence in execution of clinical studies and program(s) with trial operations

• Leads the cross-functional Clinical Study Team driving innovation to deliver study objectives on time and within budget, to the highest quality standards

Responsibilities:

• Develop, manage and revise the Study budget

• Review and develop the Study Protocol and the SIS/ICF and any other required study tools

• Responsible for Feasibility/Country Selection by developing Feasibility Questionnaire, contribute to process

• Manage the study Risk and develop risk Mitigation Plan. Leading Study risk mitigation and contingency plan

• Lead CST communication, reporting and stakeholder engagement

• Review regular vendor status reports. Be the escalation point for vendor issues which may impact study timelines, budget or quality

• Responsible for the Study Planing. Develop Study Timelines and follow-up planning execution to reach the study milestones

• Ensure overall study quality management and inspection readiness, lead deviation management process

Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).

• 5+ years of management responsibility

• Proven leadership skills

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

MUST HAVES

• Early Phase Oncology Experience -- 1, 1a, 1b, 1/2

• FDA and EMA Submissions

• Strong understanding of pharmaceutical product experience and life cycle management

Knowledge, Skills and Abilities:

• Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines

• Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost)

• Excellent oral and written communication and presentation skills

• Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams

• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity)

• Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment

• Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management

• Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness

• Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management

Our 4i values: 

• Integrity - Innovation - Intensity - Involvement - 

If you resonate with our four principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.   Please note only short-listed candidates will be contacted.

*Work Environment Requirements: *

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 

PPD® FSP: People Who Deliver | PPD Careers (https://www.ppd.com/careers/2021/02/ppd-fsp-people-who-deliver/)  - Read about PPD employee experiences! 

*LI-MP1

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.