Sr. Clinical Director, Clinical Development, Hematology TA

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Purpose

The Sr. Global Clinical Program Director (Sr CD) is a key role responsible for global implementation of clinical development plans for Hemophilia Gene Therapy and other leading pipeline assets. The position provides innovative scientific and operational leadership to translate CD strategies products into patient benefit through the safe, efficient and timely execution of assigned clinical programs. The Sr CD will contribute to study design and the development of trial related documents, is responsible for medical oversight of clinical trials and will contribute to the medical/scientific analysis and interpretation of clinical data and the writing of clinical study reports and regulatory submission documents. In addition, the Sr CD is a key member of clinical development, operational and safety/risk management teams for assigned products.

This recruitment should be an experienced Hemophilia and/or Gene Therapy expert known to the research and clinical community with a record of hemophilia/gene therapy drug development experience or the equivalent academic experience (e.g. grants, publications, society activities, etc.).

Job Description

1. Internal activities include:

• Support multiple planned Advisory Boards
• Attend Hemophilia and Gene Therapy Symposia ad speaker, panelist, etc.
• Medical Lead for Project Strategy Team
• Work with Medical Affairs to develop medical education content and programs
• Participate as medical expert in cost effectiveness reviews and payor panels
• Help prepare regulatory submissions (FDA, EMA, PMDA, etc.)
• Generate real world and QoL data in support of projects
• Oversight of long-term patient registries (ATHN14, WFH Gene Therapy)
• Plan Ph 4 studies when indicated

2. External - become the face of the company for Hemophilia Gene Therapy

Attend multiple scientific meetings as speaker, presenter, panelist, symposia lead (~20-30 meetings over 2-3 years)

• American Society of Hematology (ASH)
• International Society of Haemostasis and Thrombosis (ISTH)
• The Hemostasis and Thrombosis Research Society (HTRS)
• National Hemophilia Foundation (NHF)
• World Federation of Hemophilia (WFH)
• European Association for Haemophilia and Allied Disorders (EAHAD)
• American Society of Gene and Cell Therapy (ASGCT)
• Attend Global Advisory Boards to support launch for global programs, regional and affiliates
• Attend CSL sponsored Global Symposia to support launch
• Interact with Corporate Communications

3. Responsible for concept development and design of clinical trials and contributes to the integration of clinical strategy into the overall clinical development plan.

4. Participate in or lead a matrixed clinical development team, responsible for the generation and maintenance of a scientifically sound clinical development plan aligned with regulatory and commercial strategies and act as the primary clinical strategy representative on the core project team and on safety/ risk management teams.

5. Responsible for clinical development aspects of project planning, protocol concept development and clinical trial design, generation of study synopses, and assessment of clinical study results. Provide medical review for study relevant documents such as protocols, clinical study reports, Investigator Brochures and review study specific plans covering aspects such as data coding conventions and data reconciliation procedures, statistical analysis plans and informed consent documents, and provide review of final study reports. Responsible for study specific medical responsibility plans to document medical monitoring activities (CSL versus CRO) required for a specific study.

6. Contribute to the writing of clinical efficacy components of regulatory dossiers through authoring key clinical sections and provide oversight to contributions from Clinical Scientists and Safety as relevant. Provide advice on the clinical aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle. Lead/ contribute to the preparation of clinical sections for regulatory meetings and attend and present at such meetings (e.g. pre-IND or end Phase II meetings/ Scientific Advice/ Advisory Boards) where required.

7. Act as Medical Monitor serving as the physician contact for an Investigator site and providing medical expertise for answering specific inclusion/exclusion criteria questions and resolving study related issues. Accountable for overall medical and safety decision making at the study level. Lead the medical review for data monitoring committees and end point adjudication boards as required.

8. Actively participate in publication planning, Clin Comm. reviews and Global Business Teams to ensure close collaboration with Commercial Development and Medical Affairs.

9. Provide day-to-day oversight to Clinical Scientists for day to day program specific deliverables. Contribute to the development of Clinical Scientists through active participation in training and mentoring activities.

Reports To: VP Clinical Development, Hematology TALT Co-lead

Direct Reports: TBD

Job Requirements:

Education

Advanced degree (MD or MD/PhD) in life science/healthcare required. MD - Board Certified (or non-USA equivalent) in Hematology or Hematology/Oncology required.

Experience

Depending on academic background, at least 5 years of clinical development experience with a good knowledge of pharmaceutical and regulatory development processes is essential. This may be from experience in either industry or academic positions, although the latter would also require experience in working with industry sponsors.

Competencies

-Strong leadership and communication skills and a demonstrated ability to develop constructive and effective relationships

-Able to build and lead effective, well integrated, collaborative teams

-Works successfully in a matrix organization with multiple disciplines and to build collaborative relationships

-Able to think globally and contemplate multiple aspects and impacts of issues and plan proactively

-Able to facilitate brainstorming in teams and bring the creative thoughts of others to fruition

-Able to drive for results through self-motivation and through leading others

-Independently minded and focused; able to take decisions and be professional and supportive in driving change

-Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters

Working Conditions

Location based in KoP offices

Travel Requirements

TBD