Global Clinical Lead- Hematology

Reporting to the   Head , Global   Clinical Development  t he Global Clinical Lead   (GCL)   will act in a key leadership role in the   C linical   D evelopment   (CD)   group;

Providing s trategic and tactical   M edical   & Scientific   leadership and guidance for clinical development activities for 5-8   Global Clinical Program Leaders ( GCPL )

Serving as the CD   representative on the   Therapeutic Area Leadership team (TALT)   for   CVR   TA

May   act as any of the following roles in clinical development:   G CPL , Early Clinical Development Lead, B usiness   D evelopment (BD)   C ontributor , Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Lead   as appropriate for   p rojects as   assigned per business need

Main Responsibilities and Accountabilities:  

GCL Line Manager responsibilities include:

Providing strategic and tactical medical leadership and guidance for clinical development   activities in   for 5-8   GCPL s

Works with   other GCLs   and head of clinical to ensure adequate resourcing across the portfolio

Manages team of   clinical drug developers , acts as a mentor to physician group in guide clinical development   expertise   in general and in specific areas of therapeutic knowledge

GCL   TALT   CD   Representative   r esponsibilities   include : 

Defin ing   the   global clinical development strategy for all projects in TA

Contributing to BD strategy & due diligence for TA &   identifies   and evaluates NPO ’ s

Ensur ing   high quality clinical & scientific content is provided   into   Regulatory submissions & ensures defense and negotiation with Regulatory agencies

Prepar ing   for stage-gate evaluations and benefit   – risk evaluations and assessments

Oversee ing   and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and Global   P roject   L eaders to   ensure   optimal   clinical strategy,   CDP   and   protocol design to support   optimal   Project strateg y

GCL Other Responsibilities include:

Be an active member of the Clinical Development Leadership Team, improving the overall quality   of the group and its deliverables

Ensur ing   that the patient and physician voice is at the forefront in strategy development

Build ing   networks with external experts

Driv ing   excellence in clinical development execution

Partner ing   with TA core, extended core & functional partners to ensure scientific & medically robust clinical   dev & med affairs activities

Enhanc ing   the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA

Represent ing   the Co & TA externally with KOL, Health   Technology   and external authorities at key forums

Ensuring e ffective presentation s   at S cientific and   T echnical   R eview   C ommittee

Representing   the clinical function on the TALT, responsible for input into   TALT   strategy,   oversee   the quality of clinical plans in the   CVR   TA.

Position Qualifications and Experience Requirements:

MD, Board Certified (or non-USA equivalent) with relevant sub-specialty highly preferred- if not Board Certified in relevant Subspecialty, then experience in that TA   is   a must .

Clinical development experience leading a therapeutic area or complex clinical program with a   working knowledge of pharmaceutical and regulatory development processes is essential

A minimum of   8- 10   years ’   experience preferred,   acquired   in either industry or academic positions,   although the latter would also require experience in working with industry sponsors

Outstanding influencing ability & collaboration skills

Proven leadership experience

Ability to work effectively in a matrix environment that includes interactions with multiple stakeholder groups; particularly   demonstrated   ability to work across the critical interfaces between Clinical and   non-Clinical   functions

Experience interacting with Health Authorities and designing programs that meet the needs of HA’s,   commercial   and payers

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 .