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Senior Director, Head of Evidence Generation

Employer
CSL
Location
King of Prussia, PA
Start date
Jul 19, 2024
View moreView less
Discipline
Clinical, Medical Affairs, Regulatory
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

This position is a critical member of the Global Medical Affairs leadership who will work and coordinate with Medical Affairs stakeholders and cross-functional stakeholders to lead the design and implementation of all Medical Affairs evidence generation projects aligned with the business strategy.

Main Responsibilities & Accountabilities

• Own the development and optimization and governance of strategic integrated evidence generation initiatives (e.g., IIS, Phase IV clinical trials, NIS, RWE) across therapeutic areas for all country and global teams, proactively anticipating any potential gaps and adjusting tactical plans to address gaps.• Provide oversight and leadership to ensure the Evidence Generation team supportsMA sponsored studies in all country affiliates, and provides strategicand scientific governance and oversight of IIS in collaboration with relevantteams within inline TAs, ensure timelines are met, contingency plans are executed where necessary and full governance is followed.• LCo-Lead with TAs to identify gaps, develop and support RWE projects for relevant disease areas and ensure effective communications,in conference presentations, publications, dossiers and other means.• Collaborates with cross-functional team members to define global evidentiary needs and expectations of key stakeholders (Regulatory bodies, HCPs, Patients/caregivers, Payers, and HTA bodies) to serve the evolving healthcare environment; Supports collaborative strategic planning and mapping of evidence generation activities with key internal stakeholders to develop aligned and integrated generation strategies and plans; Enhances collaboration between various groups within CSL through sharing of data and best practices; Provides strategic leadership and scientific direction on medical evidence activities in order to set standards for utilization of medical data, and maximize patients' access to our innovative medicines• Track and report to senior management on new and ongoing evidence generation projects globally in collaboration with Medical Operations and Communications• Educate external and internal stakeholders to enhance capability in the field of Evidence Generation. Provide functional excellence expert support and coaching to team members• Provides innovative thinking and scientific expertise into post-approval research programs and real-world evidence strategies

Qualifications & Experience Requirements

• MS degree required (preferably advanced doctoral level degree e.g., MD, PharmD, PhD), preferably in a health sciences related field with 8+ years of research related experience and/or pharmaceutical industry experience.• Minimum of 12 years in pharmaceutical/biopharmaceutical industry inclusive of Medical Affairs.• Experience with late-stage clinical studies, research collaborations and RWE Proven track record of strong leadership, project management and demonstrated ability to coach and mentor individuals.• Strong Regulatory and medical information communications knowledge and experience.• Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of stakeholders both internal and external.• Experience building and leading cross-functional team in a global matrix organization

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!

Company

CSL is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

Areas of Expertise

We focus and demonstrate global leadership in three distinct areas—rare and serious diseases; influenza vaccines; and iron deficiency and nephrology.

Rare & Serious Diseases

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.

Vaccines

As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries.

Iron Deficiency & Nephrology

With our iron deficiency and iron deficiency anemia expertise in heart failure, kidney disease, gastroenterology or inflammatory bowel disease, patient blood management and women’s health, we help patients affected by these conditions to live better, healthier lives.

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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