Full-Time
Senior Director
Specialty Project Management
Posted on 4/4/2026
CSL
10,001+ employees
Develops and delivers biotherapies and vaccines
No salary listed
King of Prussia, PA, USA
In Person
 Business & Strategy (1) |
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- Undergraduate science/business degree in relevant discipline essential, preferably with post-graduate qualifications
- Post-graduate qualifications in finance, business administration or related field preferable
- 10+ years pharmaceutical or biotech experience inclusive of demonstrated strong Portfolio Management, Project Management and Team Leadership expertise
- Leadership experience in drug development in China and Japan, submissions and/or Search & Due Diligence PM
- Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences
- Excellent Strategic Thinking skills
- Executive presence and negotiation skills; Ability to effectively engage across the enterprise, building constructive relationships to execute deliverables.
- R&D Specialty Program Management: Accountable for providing Program Management leadership within the Specialty portfolio and across geographies, including New Product Development and Life Cycle Management
- Lead the Specialty Project Management function within R&D Portfolio & Operations Excellence, setting strategy and operating model for complex, cross-functional programs that include regional execution (China & Japan), regulatory submission delivery, and Search & Due Diligence/Business Development evaluations.
- Establish clear role definitions, governance, and ways of working across Specialty PM areas and regions to ensure consistent delivery standards and decision-making cadence.
- Ensure all programs and submissions under Specialty PM oversight adhere to internal quality systems, compliance expectations, and documentation standards.
- Embed risk management discipline: early detection, mitigation plans, and escalation pathways, including proactive compliance considerations for China & Japan.
- Serve as a senior PM thought leader, advising R&D and functional leaders on program strategy, sequencing, trade-offs, and execution risk across the development lifecycle for the Specialty projects.
- Lead identification of project acceleration and risk management options, while ensuring solutions are pragmatic and flexible to allow for innovation
- Actively contribute as a member of PPE Leadership Team to enable success of the group and create a culture of connectivity, delivery, empowerment and transformation
- Provide guidance and direction to the R&D Specialty Project Management teams to ensure robust, yet pragmatic, Project Management practices and methodologies are applied and aligned with broader R&D projects within our portfolio
- Liaise with the TA Delivery Leads to ensure that processes and delivery outcomes are aligned across the Therapeutic Areas (TA) and Specialty Project Management
- Ensure seamless interactions between Specialty PM and critical partners (i.e. TALTs, GPLs, PMs, RPLs, PSTs and functional representatives)
- Contribute to the development of cross functional TA strategy and process to ensure product strategy plans align with the TA strategy
- Works with Portfolio Management team to ensure Specialty portfolio information is effectively integrated into portfolio plans and analysis to support TA portfolio investment management and the development of TA strategic priorities
- Works with the TALT and Portfolio Delivery Leads to review projects in the portfolio including timelines, cost and resources
- Regional PM Leadership (China & Japan): Directly manage China PMs and work closely with the Head, R&D Japan (dual reporting model) to develop regional Project Managers supporting R&D work in China and Japan, ensuring alignment with global program strategies and local requirements.
- Integrate China/Japan PM planning into global integrated development plans (IDPs) and timelines, ensuring seamless handoffs and transparency across regions.
- Drive consistent use of tools, templates, and standards across regions and cultures while enabling locally optimized execution and stakeholder management.
- Build strong partnerships with local R&D leadership, Clinical Operations, Regulatory, Quality, Medical Affairs, Commercial Operations, and external partners to remove barriers to project delivery.
- Submissions PM Leadership: Lead Submissions PM capability across R&D, ensuring robust planning and execution for key submissions (e.g., IND/CTA, NDA/BLA/MAA variations, lifecycle submissions) including end-to-end submission planning and execution, including authoring, review, publishing, and submission readiness.
- Ensure submission plans are inspection-ready, traceable, and aligned to global regulatory strategy, including milestone discipline, authoring readiness, and contingency plans.
- Coordinate cross-functional submission governance including Regulatory Affairs, Clinical, Biostats, Medical Writing, CMC, Safety, Quality, Labelling, and Publishing.
- Search & Due Diligence (S&D) Project Management Leadership: Lead S&D PM to deliver high-quality diligence planning and execution for internal pipeline opportunities, licensing, acquisitions, collaborations, and external innovation evaluations.
- Work closely with the Search function and the Search and Due Diligence (DD) PM supports R&D and Commercial NPO due diligence activities
- Create standardized diligence workplans, functional request workflows, and executive readouts to enable fast, rigorous decision-making.
- Coordinate diligence activities across R&D, Regulatory, CMC, Safety, IP/Legal, Finance, Commercial, and external parties while ensuring confidentiality and clean-team requirements (where applicable).
- Talent/Management Responsibilities & Accountabilities: Lead a global group of PMs with a set of high-complexity and interfaces; requires oversight of global sub-functions, with individual strategies and objectives
- Establish strategic priorities, competency framework and performance expectations designed to support and develop talent to excel and grow professionally
- Lead and manage Specialty PM workforce planning: capacity, capability mix, sourcing strategy (FTE/contract), and succession planning.
- Build PM capability through coaching, mentoring, performance management, and targeted development plans, including region-specific talent strategies for China & Japan.
- Build and sustain deep expertise in regional PM, submissions PM and diligence PM as specialized capabilities.
- Champion training pathways for submissions PM and Search & DD PM specialization, ensuring consistent competency progression.
CSL is a global biotechnology company that develops and delivers biotherapies and influenza vaccines. It focuses on plasma-derived and recombinant therapies for rare and serious diseases and sells to healthcare providers, hospitals, and governments across the Americas, Asia Pacific, and Europe. Its product range includes treatments for rare diseases, influenza vaccines, and antivenoms, produced through its R&D, manufacturing, and distribution operations. CSL differentiates itself by offering the broadest portfolio of plasma-derived and recombinant therapies and by leveraging its global footprint and emphasis on diversity to reach diverse markets. The company’s main goal is to save lives and protect health by expanding access to high-quality therapies and vaccines worldwide.
Company Size
10,001+
Company Stage
IPO
Headquarters
Parkville, Australia
Founded
1916
Simplify's Take
What believers are saying
- HEMGENIX gene therapy sustains 37% factor IX levels through four years post-2025 data.
- KOSTAIVE self-amplifying mRNA COVID vaccine approved by EC February 2025.
- VarmX $2.2B acquisition option expands bleeding disorder pipeline in 2026.
What critics are saying
- Seqirus separation triggers $500M charges and 14% revenue loss from Pentagon mandate scrap.
- Grifols opens 20 plasma centers by 2027, eroding CSL Behring's immunoglobulin share.
- Novartis Fabhalta displaces CSL Vifor's $1.5B nephrology revenues within 12 months.
What makes CSL unique
- CSL Behring leads plasma-derived therapies for haemophilia and immunodeficiencies.
- CSL Seqirus dominates influenza vaccines with global production scale.
- CSL Vifor specializes in iron deficiency and nephrology treatments post-2022 acquisition.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
401(k) Retirement Plan
401(k) Company Match
Paid Time Off
Paid Vacation
Paid Sick Leave
Paid Holidays
Company News
In a high-stakes move that could reshape emergency medicine, global biotech giant CSL has struck an exclusive option agreement to acquire VarmX, a Netherlands-based biotech, in a deal valued at up to $2.2 billion. The announcement, made Tuesday by EQT Life Sciences, which counts VarmX in its portfolio, underscores just how valuable the Dutch company’s CSL to acquire VarmX in a $2.2B deal, backing breakthrough bleeding drug VMX-C001 with full trial funding.
Global biotechnology leader, CSL, celebrated the Company’s 25th Anniversary of listing on the Australian Securities Exchange (ASX), commemorating the occasion with a ceremonial bell ring at...
Automated Logic – Canada, Ltd. (ALC), part of Carrier Global Corporation, has acquired Control Solutions, Ltd. (CSL), an independent provider of building-automation systems in Coquitlam, British Columbia. This acquisition establishes ALC's first field office in Vancouver, expanding its presence in Western Canada and enhancing its ability to deliver intelligent building solutions in high-growth sectors across British Columbia.
Vienna, Austria – 9 April 2025 - CSL Behring Austria today announced that the first haemophilia B patient in Austria was treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at the Comprehensive Care Center of the University Hospital of Medicine Vienna.HEMGENIX® is the first one-time gene therapy approved in Europe for the treatment of adults with severe and moderately severe haemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1“It is a great opportunity for people with hemophilia B to live a symptom-free life for many years,” explains hematologist Univ.-Prof. Priv.-Doz. Dr Cihan Ay from the Medical University of Vienna, University Clinic for Internal Medicine I Clinical Department for Hematology and Hemostaseology."For the community of affected patients and their families, this represents an enormously significant milestone: the ability to treat hemophilia with gene therapy, and the fact that this option is now available in Austria, is something our community has been eagerly anticipating and hoping for over decades," says Thomas Schindl, MA, Chairman of the Austrian Hemophilia Society (ÖHG)."We are proud and grateful to offer haemophilia B patients in Austria a treatment option that has the potential to transform their lives," said Dr Beate Natmessnig, Managing Director of CSL Behring Austria. "This achievement is the result of outstanding regional and national collaboration among all parties involved and is a strong testament to Austria's innovative capabilities."HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022
Marburg, Germany, 2 April 2025 – CSL Behring and the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) have successfully concluded negotiations on the reimbursement price of HEMGENIX®. This agreement marks the availability of the first gene therapy approved in Europe for haemophilia B under an innovative, national, success-based reimbursement model, being implemented for the first time in Germany.HEMGENIX® represents significant progress in the treatment of haemophilia B. The aim of this one-time gene therapy is to eliminate the need for regular factor IX infusions, thereby offering patients the possibility of more freedom from prophylaxis and significantly improving their quality of life.1-4 This development not only provides substantial relief for those affected but also has the potential to reduce long-term costs for the healthcare system.‘The performance-based payment model at national level which was agreed with the GKV-Spitzenverband is unique in Germany. It addresses key reimbursement challenges, such as the question of long-term efficacy, which is inherent for any one-time therapy. Reimbursement is linked to treatment success of the individual patient,’ explains Stefan Neudoerfer, CSL Behring's chief negotiator in Germany.Moreover, this reimbursement model reflects the high therapeutic and innovative value of HEMGENIX® and sets new standards for integrating innovative gene therapies into the German healthcare system.‘The agreement on the reimbursement price of HEMGENIX® is a decisive step for the care of people with haemophilia B in Germany. It enables access to a groundbreaking therapy and recognises the long-term medical and economic benefits of gene therapy,’ explains Christian Wieszner, Managing Director of CSL Behring Germany.With this agreement, CSL Behring is underlining its commitment to innovative therapies that sustainably improve the lives of patients