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Director, Portfolio Development Process & Standards Lead

CSL Behring -
King of Prussia, PA

Apply Now

Job Details

Full-time
$230,000 - $270,000 a year

Qualifications

Training program design for professional development
Product development research management
Product development project management
Process design
Overseeing curriculum development
Global team management
Change management
Policy & process development
Product development projects
Clinical research compliance
Technology management experience
Quality assurance standard operating procedures
Managing clinical research teams
Leading team collaboration initiatives
Clinical trial standard operating procedures
Managing projects
Technical skills instruction
Operational excellence initiatives
International corporation experience
Process improvement planning
Document change management
Clinical trial support in drug product development
Cross-functional team management
Pharmaceutical research experience
Standard operating procedures (SOPs)
Project stakeholder communication
Cross-functional communication
Standard operating procedures drafting
Stakeholder management

Full Job Description

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Director, Portfolio Development Process & Standards Lead? This position is located in our King of Prussia, PA Waltham MA or Maidenhead UK office. It is a hybrid role three days onsite. You will report to the Head, Porfolio Development Excellence, Process & Compliance.

You will be responsible for establishing and maintaining a framework that allows the Global Portfolio Development group, in collaboration with multiple partner functions across the organization, to plan, evaluate and report clinical trials and programs under highest quality standards

REQUIREMENTS:

Portfolio Development Excellence: Procedures, training, continued learning, and guidance

Manages all Portfolio Development (CD/BM/CO) owned SOP updates in collaboration with critical partner SMEs where appropriate and ensures they are updated to reflect current processes and structure
Drives the development of a fit for purpose technical training curriculum across PD that supports achieving quality program goals and standards.
Provides guidance on process/procedural expectations and stakeholder management.

Driving excellence through change management and objectives oversight in partnership with PD Chief of Staff

Tracks and manages all Portfolio Development sponsored process development / improvement initiatives, in collaboration with the appropriate delegates and surface to PD CoS Identifies and drives cross functional initiatives to bring in technology
May sponsor or lead cross-functional initiatives supporting design and execution excellence
Tracks and manages all procedural documents update requirements to ensure compliance across the department in collaboration with the Portfolio Development Leadership Team and appropriate delegates.
Provides innovative solutions to increase the excellence of Portfolio Development; aiming to reduce complexity, increase quality and speed, and reduce decision making churn.
Represents Portfolio Development for applicable cross-functional R&D initiatives and forums.
Core reviewer on all Portfolio Development SOP updates to ensure changes work systematically across procedural documents.

QUALIFICATIONS:

Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
12+ years experience in the biotechnology or pharmaceutical industry (or biomedical research organization)
In-depth knowledge of drug development and GCP environment
5+ years experience in managing projects in Clinical Research and Development, first-hand experience in the execution of clinical trials is required
3+ years experience in managing process improvement initiatives, and influencing change in an organization.
Proven experience in leading cross-functional, multicultural and international (product development) teams

The expected base salary range for this position at hiring is $230,000- $270,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for Waltham MA at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Apply Now

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Director, Portfolio Development Process & Standards Lead

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