Nearly 37 million Americans are currently affected by Chronic Kidney Disease.
37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
The Associate Director, Clinical Trial Project Planning and Reporting Lead oversees the quality and timeliness of deliverables for the relevant assigned clinical project teams and ensures standards and best practices are consistently employed to provide high quality deliverables and service.
This role will be responsible for compiling, managing and reporting information from cross functional resources in the development of study level plans and operational support required for Akebia sponsored studies.
Additionally, they are responsible for producing the required or needed set of study status reports at defined intervals (including resource management projections).
Together, these analytics and planning activities play a key role in supporting the cross functional teams in the operational delivery of studies.
The Clinical Planning and Reporting Lead ensures that planning and feasibility activities and strategies are aligned with Akebia study team goals.
This position is accountable for generation and maintenance of project schedules and project resource forecasts to enable the Project Team/Therapeutic Area to meet strategic objectives.
The Clinical Trial Project Planning and Reporting Lead will ensure that project plans are created in accordance with defined study and project plan standards & portfolio/project goals.
They are responsible for maintaining accurate schedules and resource information within specified planning systems.
Additionally, they produce various levels of schedules/plans and other related reports to support Medical Team Leads, Clinical Project Managers, Clinical Leads and others.
They are also responsible for performing scenario planning of cost, schedule & resource demand to enable optimum use of funding, resources & efficient delivery of project milestones.
Support includes project and protocol level planning and status reporting and requires interfaces with team members from other functional lines such as Clinical Ops, Development, Finance, Project Office, etc.
Responsibilities will include:
- Consistent use and quality of project planning global standards
- Partners with clinical study/project teams and other colleagues as appropriate to engage at the portfolio level for strategic disease area and/or indication planning
- Drives support of Clinical Ops ‘Operational Reviews’ and any additional reporting requests
- Liaise with functional leaders to collect information necessary to maintain study databases as defined.
- Ensure the creation of standardized reports which reflect program and study status are distributed accordingly.
- Preparation of monthly metrics reports of activities relating to planned and ongoing clinical trials,
- Be the key contact for internal Akebia organizations which require study status such as Finance, QA, PMO and Leadership.
- Assist in the preparation of annual financial planning using standard resourcing models and tools.
- Be familiar with protocols and programs to be able to support clinical objectives and study performance through resource management and planning.
- Works directly with internal clinical lead and vendors as appropriate to the situation.
- Maintains timeline and resource management plans which may be easily adjusted to provide models for multiple scenarios.
- Joint responsibility with clinical lead for setting and baselining of timelines, and progress against study goals.
- Tracks study status against defined milestones such as enrollment, study start up, FPI LPO and other activities impacting resourcing.
Required Skills
Responsibilities will include:
- Consistent use and quality of project planning global standards
- Partners with clinical study/project teams and other colleagues as appropriate to engage at the portfolio level for strategic disease area and/or indication planning
- Drives support of Clinical Ops ‘Operational Reviews’ and any additional reporting requests
- Liase with functional leaders to collect information necessary to maintain study databases as defined.
- Ensure the creation of standardized reports which reflect program and study status are distributed accordingly.
- Preparation of monthly metrics reports of activities relating to planned and ongoing clinical trials,
- Be the key contact for internal Akebia organizations which require study status such as Finance, QA, PMO and Leadership.
- Assist in the preparation of annual financial planning using standard resourcing models and tools.
- Be familiar with protocols and programs to be able to support clinical objectives and study performance through resource management and planning.
- Works directly with internal clinical lead and vendors as appropriate to the situation.
- Maintains timeline and resource management plans which may be easily adjusted to provide models for multiple scenarios.
- Joint responsibility with clinical lead for setting and baselining of timelines, and progress against study goals.
- Tracks study status against defined milestones such as enrollment, study start up, FPI LPO and other activities impacting resourcing.
The Associate Director, Clinical Functions and Program Operations Lead is accountable for tracking the delivery of study goals against targets, including specific operational metrics.
This position works in a matrixed relationship with the relevant functions including Clinical Operations, Clinical Development and Finance and partners directly with Akebia planning organizations (such as PMO) to coordinate strategic and timely study-level planning and Clinical Trial operational analytics.
Required Experience
Basic Qualifications:
- BS in health care or related science or business and 8 years’ relevant experience in the pharmaceutical industry or
- MS in health care or related science or business and 6 years’ relevant experience
Preferred Qualifications:
- Previous direct line management experience within the pharmaceutical industry preferred
- Experience in data analyses and interpretation
- Strong knowledge of project management, project planning, and resource management practices, principles, and supporting systems and tools
- Comprehensive knowledge of clinical trial methodology; clinical drug development processes related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment along with the collection, computerization, and reporting of data from clinical trials
- Independent judgment and decision-making skills with respect to functional responsibilities
- Demonstrated ability to manage complex projects and cross-functional processes
- Continuous improvement experience preferred
- Multi-cultural awareness
- Ability to use software and maintain systems to store, retrieve and generate information is required
- Strong written and verbal communication skills
- Fluent in English (oral and written)
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas.
Akebian’s aren’t afraid of diving in and owning a process or a problem, because we all want to deliver a great solution.
Akebian’s believe that we are better together because we are all working toward a common purpose – to better the life of each person impacted by kidney disease.
All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.
Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.
Akebia is an equal opportunity employer and welcomes all job applicants.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.