Clinical Program Director

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jun 10, 2021
Ref
R-130955
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

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 Overview

The Global Clinical Program Director (CPD) is a key role within Clinical Research and Development (CRD) responsible for global implementation of clinical development plans for assigned products in the therapeutic area. The role requires scientific and operational leadership to translate CRD strategies into patient benefit through the safe, efficient and timely execution of clinical studies. The CPD will contribute to product strategy and clinical development plans, through a key role on a clinical development team (CDT). The CPD is responsible for the overall medical oversight (medical monitor) of assigned clinical studies. The CPD will also contribute to the medical/scientific analysis and interpretation of clinical trial data and participate in the writing of clinical study reports and regulatory submission documents. In addition, the CPD is a key member of safety/risk management teams for assigned products/assets.

Main Responsibilities:
1. Responsible for concept development and design of clinical trials and contributes to the integration of clinical strategy into the overall clinical development plan.
2. 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.
3. 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.

4. 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.

5. Responsible for study specific medical responsibility plans to document medical monitoring activities (CSL versus CRO) required for a specific study.
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.

6. Provide advice on the clinical aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development life cycle. 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. In collaboration with Commercial (Development/Operations) and Clinical Operations identify key investigators. Develop and maintain relationships with lead investigators within assigned therapeutic area. Additionally, actively participate in investigator meetings.
8. 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.

9. Accountable for overall medical and safety decision making at the study level.

10. Lead the medical review for data monitoring committees and end point adjudication boards as required.
11. Contribute to the identification of and assist in providing direction to clinical consultants. Contribute to Scientific Advisory Board activities to support clinical development strategy and discussion.
12. Act as an internal clinical therapeutic expert developing and maintaining an understanding of key disease states/etiology, treatments, therapeutic trends, competitive agents for the indications and development projects within the assigned therapeutic area.
13. Actively participate in publication planning, Clinical Committee reviews and Global Business Teams to ensure close collaboration with Commercial Development and Medical Affairs.
14. Provide day to day oversight to Clinical Scientists for day to day program specific deliverables.

15. Contribute to the development of Clinical Scientists through active participation in training and mentoring activities.
16. Participate in due diligence on external business development opportunities to expand Clinical Research & Development portfolio

Education and Qualifications:
MD - Board Certified (or non-USA equivalent) .
Depending on academic background, at least 3 years of clinical development experience with a working knowledge of pharmaceutical and regulatory development processes is essential. This could have been acquired 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