Senior Project Manager - Biomarker

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Summary/Scope

In this position you will be part of the Immunology, Cardiovascular, and Fibrosis Translational Development Disease Team for our client based in Princeton, NJ. The individual will support clinical biomarker activities to support drug development programs in immunology and fibrosis. This individual will have the opportunity to guide and execute research projects through implementation of biomarker plan, data delivery and analysis of biomarkers in clinical studies. The successful candidate preferably will have prior experience interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines for patients with unmet needs.

Responsibilities will include, but are not limited to, the following: Implements biomarker plan, develops in-depth understanding of clinical studies of assigned projects, manages the timelines and activities associated with biomarker data delivery such as setting up biomarker analysis request, following through projects with CRO, adapting with protocol amendment, tracking statistical analysis progress and generating detailed report of the biomarker analysis in parallel with clinical study progress Tracks availability of biomarker data and rapidly perform analyses of preliminary data. Performs literature research and synthesizes/summarizes key points and concepts that are applicable to projects Implements translational activities through interaction with clinical team, statisticians, computational biologists and internal translational scientists Manages biomarker data delivery for clinical studies through working with relevant functions and CROs; responsible for aiding in creation of SOWs and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. Evaluates CROs for data analysis and delivery capabilities, in conjunction with Translational Sciences and Precision Medicine Provides guidance on clinical biomarker data analysis to Global Biometrics, and Informatics and Predictive Sciences Maintains timelines for biomarker data related publications through interaction with Medical Communications and Publication team Prepares and delivers presentations within the department and externally

Tasks and Responsibilities:

• Completes biomarker data generation related assignments by designing analysis and interpreting multi-parameter data readouts.

• Work on cross functional assignments and maintains timelines.

• Manages and/or coordinates workflow on biomarker projects.

• Ability to recognize, articulate, and accept calculated risks to make informed decisions

• Interpret results.

Discretion/Latitude:

• Helps design biomarker analysis plan consistent with department goals.

• Provides input and makes recommendations to research strategies and publication plans.

Creativity and Problem Solving:

• Identifies & solves multi-faceted challenges.

• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.

• Identifies risks and develops mitigation plans.

• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

*LI-SW1

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Summary/Scope

In this position you will be part of the Immunology, Cardiovascular, and Fibrosis Translational Development Disease Team for our client based in Princeton, NJ. The individual will support clinical biomarker activities to support drug development programs in immunology and fibrosis. This individual will have the opportunity to guide and execute research projects through implementation of biomarker plan, data delivery and analysis of biomarkers in clinical studies. The successful candidate preferably will have prior experience interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines for patients with unmet needs.

Responsibilities will include, but are not limited to, the following: Implements biomarker plan, develops in-depth understanding of clinical studies of assigned projects, manages the timelines and activities associated with biomarker data delivery such as setting up biomarker analysis request, following through projects with CRO, adapting with protocol amendment, tracking statistical analysis progress and generating detailed report of the biomarker analysis in parallel with clinical study progress Tracks availability of biomarker data and rapidly perform analyses of preliminary data. Performs literature research and synthesizes/summarizes key points and concepts that are applicable to projects Implements translational activities through interaction with clinical team, statisticians, computational biologists and internal translational scientists Manages biomarker data delivery for clinical studies through working with relevant functions and CROs; responsible for aiding in creation of SOWs and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. Evaluates CROs for data analysis and delivery capabilities, in conjunction with Translational Sciences and Precision Medicine Provides guidance on clinical biomarker data analysis to Global Biometrics, and Informatics and Predictive Sciences Maintains timelines for biomarker data related publications through interaction with Medical Communications and Publication team Prepares and delivers presentations within the department and externally

Tasks and Responsibilities:

• Completes biomarker data generation related assignments by designing analysis and interpreting multi-parameter data readouts.

• Work on cross functional assignments and maintains timelines.

• Manages and/or coordinates workflow on biomarker projects.

• Ability to recognize, articulate, and accept calculated risks to make informed decisions

• Interpret results.

Discretion/Latitude:

• Helps design biomarker analysis plan consistent with department goals.

• Provides input and makes recommendations to research strategies and publication plans.

Creativity and Problem Solving:

• Identifies & solves multi-faceted challenges.

• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.

• Identifies risks and develops mitigation plans.

• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

*LI-SW1

Education and Experience:

• Bachelor's in a scientific discipline

• 8 years experience in (pharmaceutical) project management

• Executive level presentation experience

Knowledge, Skills and Abilities: Strong science and/or business acumen Understanding of drug development process At least 2 years of Biomarker Project Management are required. Experience in interacting with CROs and KOLs to manage projects and timelines Proven scientific/leadership expertise (working in teams, managing projects) Accountable for timelines and deliverables Prioritizes risks and implements contingency plans Outstanding communication skills; communicates regularly, prepares and delivers presentations within the group and department Recognizes cross-functional issues and communicates within the larger organization. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks. Experienced in a cross-matrixed organization Ability to prioritize and manage time efficiently Strong verbal and written communication skills Accurate and detailed record keeping Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Extensive knowledge and experience in Project Management Strong client relationship management skills Ability to work effectively with multi-level teams Ability to work in a fast-paced undefined environment Strong negotiation skills

Working Environment

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. 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 and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Education and Experience:

• Bachelor's in a scientific discipline

• 8 years experience in (pharmaceutical) project management

• Executive level presentation experience

Knowledge, Skills and Abilities: Strong science and/or business acumen Understanding of drug development process At least 2 years of Biomarker Project Management are required. Experience in interacting with CROs and KOLs to manage projects and timelines Proven scientific/leadership expertise (working in teams, managing projects) Accountable for timelines and deliverables Prioritizes risks and implements contingency plans Outstanding communication skills; communicates regularly, prepares and delivers presentations within the group and department Recognizes cross-functional issues and communicates within the larger organization. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks. Experienced in a cross-matrixed organization Ability to prioritize and manage time efficiently Strong verbal and written communication skills Accurate and detailed record keeping Strong verbal, written and presentation skills Superior time management, planning, and organizational skills Proven analytical skills Demonstrated compliance with procedures and policies Ability to perform multiple tasks effectively in a stressful environment Extensive knowledge and experience in Project Management Strong client relationship management skills Ability to work effectively with multi-level teams Ability to work in a fast-paced undefined environment Strong negotiation skills

Working Environment

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. 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 and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.