SVP, Head of Clinical Pharmacology, QSP & Translational Sciences

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

BioCryst is seeking an exceptional scientific leader to serve as Senior Vice President & Head of Clinical Pharmacology, Quantitative Systems Pharmacology (QSP) and Translational Sciences. Reporting directly to the Chief Research & Development Officer, this individual will lead the integration of clinical pharmacology, translational medicine, model-informed drug development (MIDD), quantitative systems pharmacology, pharmacometrics, biomarker sciences, and advanced computational approaches across BioCryst's portfolio.

This executive will be a key member of the R&D Leadership Team and will play a critical role in transforming scientific and clinical data into actionable decisions that improve target selection, translational strategy, dose optimization, clinical trial design, and regulatory success. The role will be instrumental in advancing BioCryst's vision of becoming a leading data-driven biotechnology company, leveraging cutting-edge modeling, mechanistic disease understanding, artificial intelligence, and machine learning to increase the probability of technical and regulatory success across programs.

The successful candidate will have a demonstrated record of leadership across all phases of drug development, from candidate selection through registration and lifecycle management, with deep expertise spanning multiple therapeutic areas and significant experience in rare diseases.

This role aligns with BioCryst's strategy of strengthening translational science and modernizing scientific capabilities through AI, mechanistic modeling, and quantitative approaches.

Key Responsibilities

Enterprise Leadership

• Serve as a strategic member of the R&D Leadership Team and contribute to portfolio prioritization, governance, business development evaluations, and overall R&D strategy.
• Build and lead a world-class organization encompassing:
  • Clinical Pharmacology
  • Pharmacometrics
  • Quantitative Systems Pharmacology
  • Translational Medicine
  • Biomarker Strategy
  • Model-Informed Drug Development
  • Computational and AI-enabled Drug Development Sciences
• Recruit, develop, and retain high-performing scientific leaders and technical experts.
• Foster a culture of scientific excellence, innovation, collaboration, accountability, and continuous learning.

Clinical Pharmacology & MIDD Leadership

• Define and execute the company's global Clinical Pharmacology strategy across all development programs.
• Lead dose selection, dose optimization, exposure-response analyses, QT assessments, special population evaluations, drug-drug interaction strategies, and regulatory clinical pharmacology packages.
• Establish best-in-class Model-Informed Drug Development (MIDD) capabilities to support:
  • First-in-human dose selection
  • Proof-of-concept study design
  • Phase 2 and Phase 3 dose selection
  • Adaptive trial designs
  • Registration strategies
  • Lifecycle management
• Ensure quantitative evidence is integrated into major development and governance decisions.

QSP, Systems Biology & Translational Sciences

• Develop and implement innovative Quantitative Systems Pharmacology and mechanistic modeling approaches that integrate:
  • Human biology
  • Disease pathophysiology
  • Biomarker data
  • PK/PD relationships
  • Clinical outcomes
• Use mechanistic and systems models to improve understanding of disease biology and therapeutic intervention points.
• Translate emerging biological insights into predictive development strategies that accelerate decision-making and reduce development risk.
• Partner closely with Research, Clinical Development, Regulatory Affairs, Biometrics, and Medical Affairs to create seamless translation from discovery through registration.

Artificial Intelligence & Machine Learning

• Lead BioCryst's vision for integrating AI and machine learning into translational and clinical development decision-making.
• Develop capabilities that leverage multimodal datasets across preclinical, clinical, biomarker, genomic, proteomic, and real-world evidence sources.
• Apply advanced computational methodologies to:
  • Improve patient stratification
  • Enhance trial design
  • Predict clinical outcomes
  • Inform dose optimization
  • Identify responder populations
  • Improve probability of technical and regulatory success
• Establish a scalable framework combining mechanistic modeling and machine learning approaches for future pipeline programs.

Regulatory Leadership

• Serve as the primary Clinical Pharmacology and Quantitative Sciences representative to global regulatory authorities.
• Lead regulatory interactions involving:
  • FDA
  • EMA
  • MHRA
  • PMDA
  • Other global health authorities
• Provide strategic leadership for clinical pharmacology and MIDD content in INDs, CTAs, NDAs, BLAs, MAAs, and other global submissions.
• Represent BioCryst in regulatory meetings, advisory committees, and industry working groups.

Cross-Functional Influence

• Collaborate closely with:
  • Clinical Development
  • Regulatory Affairs
  • Biometrics & Data Sciences
  • Research
  • Medical Affairs
  • Commercial
  • Business Development
• Provide scientific leadership and quantitative assessments for external innovation and licensing opportunities.
• Communicate complex scientific concepts effectively to executive leadership, Board members, investors, partners, and regulatory agencies.

Required Qualifications

Education

• PhD in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacometrics, Systems Biology, Biomedical Engineering, Applied Mathematics, Computational Biology, Pharmaceutics, or a related scientific discipline.
• Additional clinical or postdoctoral training is desirable.

Experience

• Minimum 15 years of progressive pharmaceutical or biotechnology industry experience.
• Significant leadership experience in Clinical Pharmacology, Pharmacometrics, Translational Sciences, QSP, or related disciplines.
• Demonstrated success supporting both early-stage and late-stage drug development programs.
• Extensive experience in rare disease drug development strongly preferred.
• Broad therapeutic area experience across multiple disease areas.
• Proven track record of successful regulatory submissions and approvals.
• Substantial experience interacting directly with global regulatory agencies, including FDA and EMA.
• Experience building and leading high-performing global teams.
• Demonstrated application of MIDD approaches that materially influenced development and regulatory decisions.

Preferred Qualifications

• Recognized industry leader in Clinical Pharmacology, Pharmacometrics, MIDD, QSP, or Translational Medicine.
• Experience leveraging AI, machine learning, and advanced analytics within drug development.
• Publications, presentations, or recognized contributions in clinical pharmacology, pharmacometrics, translational medicine, or systems modeling.
• Experience across multiple modalities, including:
  • Small molecules
  • Monoclonal antibodies
  • Fusion proteins
  • RNA-based therapeutics
  • Other emerging modalities

Leadership Competencies

The ideal candidate will demonstrate:

• Visionary Leadership – anticipates future scientific and technological advances and translates them into competitive advantage.
• Strategic Thinking – balances scientific rigor with business objectives.
• Innovation Mindset – embraces emerging technologies, AI, and next-generation quantitative approaches.
• Scientific Excellence – deep expertise with strong credibility across academia, industry, and regulatory agencies.
• Enterprise Collaboration – builds strong partnerships across functions and geographies.
• Talent Development – recruits, mentors, and develops future scientific leaders.
• Communication Excellence – able to communicate complex concepts to highly technical and non-technical audiences.
• Execution Focus – drives decisions and outcomes with urgency and accountability.

Success in This Role

Within the first several years, the successful leader will:

• Establish BioCryst as a recognized industry leader in MIDD and quantitative translational sciences.
• Implement an integrated PK/PD, QSP, and AI-enabled decision framework across the portfolio.
• Improve confidence in dose selection and trial design decisions.
• Accelerate development timelines while reducing development risk.
• Strengthen regulatory interactions through science-based quantitative approaches.
• Enhance mechanistic understanding of disease biology and treatment responses.
• Increase the probability of successful clinical and regulatory outcomes across BioCryst's pipeline.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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