The Senior Director, Head of Medical Evidence reports to the Vice President, Head of Disease Areas and collaborates with Medical Affairs and cross-functional stakeholders to lead Integrated Evidence Generation Plans (IEGP) for all marketed products. This role oversees the design and implementation of Medical Affairs evidence generation projects in alignment with GxP and business strategy.
Tasks
- Oversee and deliver strategic integrated evidence generation plans (IEGPs) across therapeutic areas for pipeline and marketed medicines, including development, execution, maintenance, and governance of all IEGPs.
- Oversee design and implementation of Medical Affairs-led real-world evidence (RWE), epidemiological studies, HEOR, patient preference, and non-interventional studies.
- Guide development of phase IIIb/IV trials, registries, and observational studies.
- Ensure quality and timely delivery of study protocols, statistical analysis plans, and reports.
- Anticipate evidence gaps and proactively adjust tactical plans to meet the data needs of key stakeholders, including Regulatory authorities, HTAs, HCPs, and payers.
- Ensure all activities comply with GCP, regulatory standards, and internal policies.
- Manage budgets, timelines, and vendor relationships.
- Monitor and report on the impact of evidence generation activities.
- Oversee study tracking of all ongoing Medical Affairs evidence generation projects globally and provide regular reporting to Medical Affairs, including LT, MAST, and DA leads.
- Enhance Medical Affairs capabilities in lifecycle management and phase 3b evidence generation.
- Partner with Global Program Teams, Medical Affairs, Clinical Development, Regulatory, and Market Access.
- Lead or contribute to matrix teams and evidence generation sub-teams.
- Provide subject matter expertise and consultation to Medical Affairs colleagues in study development and design, and interact with external research partners including investigators and vendors.
- Support Medical Disease Area teams for study execution as required.
Requirements
- Advanced degree (MS/PhD/PharmD) with relevant scientific/medical background.
- Minimum of 12 years in pharmaceutical/biopharmaceutical industry inclusive of Medical Affairs.
- 8+ years’ experience in research related experience and/or pharmaceutical industry experience.
- Experience with late-stage clinical studies, research collaborations, and RWE.
- Proven track record of strong leadership, project management, and 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 teams in a global matrix organization.
- Analytical thinking.
- Business acumen.
- Customer focus.
- Communication clarity.
- Emotional Intelligence (EQ).
- Perseverance.
- Presentation expertise.
- Priority setting.
- Scientific expertise.
Benefits
The expected base salary range for this position at hiring is $303,000 - $371,000. Individual base salary is determined by qualifications, skill level, experience, competencies, and other relevant factors. Total compensation may also include incentive compensation and equity.
CSL offers benefits and supports employee well-being. Inclusion and belonging are core to the mission and culture.
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