Senior Director, Head of Medical Evidence Generation

CSL•Waltham, MA

2d•$303,000 - $371,000•Hybrid

About The Position

The Senior Director, Head of Medical Evidence reports into the Vice President, Head of Disease Areas and coordinates with Medical Affairs and cross-functional stakeholders to lead the Integrated Evidence Generation Plans (IEGP) for all marketed products and oversees the design and implementation of Medical Affairs evidence generation projects in alignment with GxP and business strategy.

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 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.

Nice To Haves

Analytical thinking
Business acumen
Customer focus
Communication clarity
Emotional Intelligence (EQ)
Perseverance
Presentation expertise
Priority setting
Scientific expertise

Responsibilities

Responsible for oversight and delivery of the strategic integrated evidence generation plans (IEGPs) across therapeutic areas for pipeline and marketed medicines. This includes development, execution, and maintenance of data gap generation and analysis and governance and documentation 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 serve 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.
Oversees study tracking of all ongoing Medical Affairs evidence generation projects globally and provides regular reporting to Medical Affairs, including LT, MAST, 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.
Provides subject matter expertise and consultation to Medical Affairs colleagues in study development and design and interact, as required, with external research partners including investigators and vendors (including but not limited to CROs, database owners, registries, et).
Provide support to Medical Disease Area teams for study execution as required.