Medical Evidence Generation Director
2 days ago
This role is a critical member of the Global Medical Affairs leadership, reporting into the Vice President, Medical Affairs Therapeutic Areas. The successful candidate 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.
Key Responsibilities:- Own the development and optimization and governance of strategic integrated evidence generation initiatives (ex. 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 supports MA sponsored studies in all country affiliates and provides strategic and scientific governance and oversight of IIS in collaboration with relevant teams within inline TAs, ensure timelines are met, contingency plans are executed where necessary and full governance is followed.
- Co-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.
- 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.
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.
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