Senior Director, Medical Affairs

CSL•Waltham, MA

About The Position

The Senior Director, Medical Affairs, Hematology Pipeline is a senior-level global leadership role responsible for architecting and executing the end-to-end Medical Affairs pre-launch and peri-launch strategy for a high-priority hematology asset. This role serves as the primary Medical Affairs point of accountability for pipeline readiness, leading a team of four direct reports across US and International regions and collaborating extensively with cross-functional enterprise partners. The successful candidate will bring deep hematology expertise, launch experience, and the strategic acumen to translate scientific evidence into compelling, compliant medical narratives that position the asset for successful market entry.

Requirements

Medical Degree (MD) with significant experience in Hematology.
12+ years of progressive Medical Affairs or related pharmaceutical/biopharmaceutical industry experience.
Clinical and/or research background in hematology strongly preferred; demonstrated understanding of the hematology scientific landscape, treatment paradigms, and evolving standard of care.
Direct experience in pre-launch and launch environments, with a track record of building and executing Medical Affairs launch readiness plans.
Experience leading or meaningfully contributing to evidence generation strategy, including RWE, observational studies, or investigator-initiated research programs.
Demonstrated people management experience, with a record of building, developing, and retaining high-performing Medical Affairs teams.
Ability to work effectively across cultural and regional contexts
Proven ability to lead and inspire cross-functional and cross-regional teams without direct authority.
Strong executive presence with the ability to represent Medical Affairs credibly at senior leadership and governance levels.
Skilled at managing through ambiguity and driving clarity and alignment in complex, fast-moving environments.
Ability to synthesize complex clinical and scientific data into clear, strategic medical narratives for diverse audiences.
Strong understanding of evidence generation methodologies and the application of data to support product differentiation and access.
Working knowledge of HEOR principles and the intersection of clinical evidence and market access strategy.
Exceptional oral and written communication skills; able to adapt messaging to scientific, clinical, commercial, and executive audiences.
Demonstrated effectiveness as a collaborative partner, building trusted relationships with both internal stakeholders and external scientific experts.
Comfort operating in a matrixed, agile organization with competing priorities and evolving timelines.
Track record of managing multiple, high-priority workstreams concurrently while maintaining quality and compliance standards.
Experience working within governance frameworks and contributing to cross-functional decision-making bodies.

Responsibilities

Lead the design and execution of a comprehensive global Medical Affairs pre-launch plan, ensuring alignment across US and International regions and readiness for peri-launch activation
Develop and oversee the integrated Evidence Generation Plan (EGP), identifying scientific gaps and prioritizing observational studies, registries, and real-world evidence initiatives to support launch objectives.
Establish and drive the Data Dissemination Plan, ensuring timely and scientifically rigorous communication of clinical and real-world data through appropriate medical channels.
Oversee the development of disease state education and product education programs for healthcare provider audiences, ensuring accuracy, balance, and compliance with regulatory and promotional standards.
Build and manage the global medical materials library for the prelaunch and peri-launch periods, including slide decks, FAQs, clinical backgrounders, and field tools.
Lead the development and execution of a global thought leader (TL) mapping framework, stratifying hematology key opinion leaders (KOLs) by influence, region, and scientific focus area.
Initiate and cultivate strategic relationships with top-tier hematology thought leaders, scientific advisors, and academic centers of excellence ahead of launch.
Coordinate advisory boards, scientific expert panels, and steering committees to generate insights that inform Medical Affairs strategy and data generation priorities.
Partner with field Medical Science Liaison (MSL) leadership to ensure consistent, high-quality scientific engagement at the KOL level.
Directly lead, coach, and develop a team of four Medical Affairs professionals across US and International regions, fostering a high-performance, collaborative culture.
Set clear objectives and performance expectations; conduct regular one-on-ones and performance reviews; actively support career development and succession planning.
Model effective navigation of ambiguity and organizational change, enabling team agility in a fast-paced, evolving pipeline environment.
Serve as a standing Medical Affairs voice in cross-functional forums, with active engagement with Commercial Development, New Product Planning, Market Access, HEOR, and regional Marketing teams.
Represent Medical Affairs in joint operating bodies including the Joint Steering Committee (JSC) and VarmX, providing scientific and strategic counsel on pipeline asset positioning.
Ensure Medical Affairs perspectives are embedded early in launch readiness planning, integrated brand planning, and product lifecycle strategy.
Maintain compliance with all applicable policies, SOPs, and regulatory requirements governing Medical Affairs activities.