Global Clinical Lead- Hematology

CSL Plasma Inc.; Waltham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

CSL Behring seeks a Global Clinical Lead (GCL) to provide strategic and tactical medical leadership for clinical development programs within the CVR therapeutic area. The role reports to the Head, Global Clinical Development and may mentor a team of GCPLs across global projects.

You will shape global development strategy, drive high-quality content for regulatory submissions, and partner with regulatory authorities to ensure robust trial design and execution.

Qualifications

• MD, Board Certified in relevant subspecialty or substantial TA experience required.
• Experience leading therapeutic programs in clinical development is essential.
• Proven ability to influence across functions and with Health Authorities.
• Strong leadership and mentoring of clinical teams in a matrix environment.
• Experience interacting with Health Authorities and regulators for study design and submissions.

Responsibilities

• Provide strategic and tactical medical leadership for global clinical development activities.
• Mentor GCPLs and ensure adequate resourcing across the portfolio.
• Define global clinical development strategy for all projects in the TA.
• Support BD due diligence and collaborate on program strategy.
• Represent the clinical function on the TALT and oversee clinical plans and protocols.

Skills

Influencing ability

Leadership

Collaboration

Matrix environment

HA interactions

Education

MD, Board Certified (or non-USA equivalent)

Job description

Reporting to the Head, Global Clinical Development the Global Clinical Lead (GCL) will act in a key leadership role in the Clinical Development (CD) group; Providing strategic and tactical Medical & 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: GCPL, Early Clinical Development Lead, Business Development (BD) Contributor, Product Strategy Team (PST) Clinical Representative, Clinical Development Team (CDT) Lead, or a Clinical Study Lead as appropriate for projects as assigned per business need

GCL Line Manager responsibilities

• Providing strategic and tactical medical leadership and guidance for clinical development activities for 5-8 GCPLs
• 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 responsibilities

• Defining the global clinical development strategy for all projects in TA
• Contributing to BD strategy & due diligence for TA & identifies and evaluates NPO’s
• Ensuring high quality clinical & scientific content is provided into Regulatory submissions & ensures defense and negotiation with Regulatory agencies
• Preparing for stage-gate evaluations and benefit–risk evaluations and assessments
• Overseeing and supports the clinical development activity of assigned Clinical Development reports and works in a matrix with CDT leads and Global Project Leaders to ensure optimal clinical strategy, CDP and protocol design to support optimal Project strategy

GCL Other Responsibilities

• Be an active member of the Clinical Development Leadership Team, improving the overall quality of the group and its deliverables
• Ensuring that the patient and physician voice is at the forefront in strategy development
• Building networks with external experts
• Driving excellence in clinical development execution
• Partnering with TA core, extended core & functional partners to ensure scientifically & medically robust clinical dev & med affairs activities
• Enhancing the reputation of the Company through thought leadership, KOL interactions in fundamental issues affecting the TA
• Representing the Co & TA externally with KOL, Health Technology and external authorities at key forums
• Ensuring effective presentations at Scientific and Technical Review Committee
• 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

To learn more about 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.

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