Sr Mgr, Program Mgmt | BioNJ Talent Services

Sr Mgr, Program Mgmt

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

PTC is biopharmaceutical company focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC’s internally-discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology and infectious diseases. For more information on the company, please visit our website www.ptcbio.com. ​

Job Description:

The Senior Manager, Program Management supports cross-functional program teams to ensure projects meet objectives and are delivered on-time.

Under the general supervision of a Manager or Director, the Senior Manager, Program Management is primarily responsible for:
Working in partnership with cross-functional program team(s) to independently develop and maintain the timelines required to support cross-functional drug development projects/programs with an emphasis on Health Authority filings.
Tracking progress towards milestones and communicating potential risks and conflicts.
Proactively identifying potential deviations via routine communications and timeline reports.
The Senior Manager, Program Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:

Primary duties/responsibilities:
Facilitates project team meetings comprised of internal and external representatives. This includes, but may not be limited to: clinical operations, data management, biostatistics, medical writing, medical monitoring, drug safety and pharmacovigilance, clinical supplies, regulatory affairs, quality, pharmaceutical development and manufacturing, finance, legal, etc. Earlier stage projects may also involve participation from discovery research (including, but not limited to: biology, medicinal chemistry, pre-clinical pharmacology and toxicology) while later stage projects may involve participation from the commercial organization (including, but not limited to., medical affairs, marketing and patient advocacy).
Functions as the primary point of contact for project teams on the status of all study-related issues, both on-going and potential, as appropriate.
Ensures the on-going alignment of project team goals and objectives by creating and maintaining high level timelines, entering updates to the plan and tracking activities to ensure alignment with target dates. Maintains correct interdependencies of activities within the timelines; identifies critical path tasks and deliverables; identifies risks/challenges and assists with the development and implementation of risk mitigation plans.
Tracks and highlights issues and provides timely updates to the project team on off-track activities.
Ensures efficient and timely communication between/across functions and with functional leadership.
Supports the efficient and timely execution of Health Authority registrations in accordance with applicable local regulatory agency regulations, guidelines, and/or specifications by developing and actively managing comprehensive, integrated and accurate submission project plans. This may involve creating detailed work breakdown structures for project and sub-team deliverables that identify and sequence activities to be completed to support drug development projects/programs and the associated Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Marketing Authorisation Applications (MAAs) and/or Biological Licensing Applications (BLAs).
Develops, maintains and communicates status dashboards for team and management visibility in key activities.
Captures and communicates key actions and decisions.
Monitors the progress of the project, makes any necessary adjustments and reviews the quality of the completed work on a regular basis.
Documents meeting minutes, action items, and key decisions to maintain program documentation and ensure aligned communication within the program team.
Coordinates internal and external meetings required to support achievement of the program objectives.
Performs other tasks and assignments as needed and specified by management.

Qualifications: 

Minimum level of education and years of relevant work experience:
Bachelor’s degree in a relevant discipline and a minimum of 6 years of related professional experience in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment including a minimum of 4 years of experience in a project management role OR an Associate’s degree in a relevant discipline and a minimum of 8 years of related professional experience in these same environments OR equivalent experience and/or education.
Special knowledge or skills needed and/or licenses or certificates required:
Proficiency with Microsoft Office including in-depth experience/proficiency with Microsoft Project.
Familiarity with SharePoint including the ability to maintain a project team site, create new folders, upload and share documents.
The ability to independently collaborate with members of the cross-functional program teams to understand deliverables, activities and decisions required to advance the project.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Excellent verbal and written communication and skills.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects including high level of attention to detail.
Strong team player with good interpersonal skills and communication skills.
Ability to multi-task and perform under demanding and aggressive timelines while remaining focused on the program goals.
Proven ability to interact effectively and efficiently with different functional groups.
Special knowledge or skills and/or licenses or certificates preferred:
Knowledge of eCTD framework and required documents to support Health Authority filings. Travel requirements:
0-5%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Project Management