Executive Director, Global Program Lead
Xeris Pharmaceuticals, Inc.
6 months ago
Remote friendly (Chicago, IL)
United States
Operations
Responsibilities:
- Lead the cross-functional XP-8121 project team to deliver on-time work aligned with compliance and quality standards.
- Oversee clinical execution (pivotal Phase 3) and product development for pre-NDA and NDA filing, including scaling for commercial volumes.
- Manage regulatory submissions (IND amendments, NDA filing and approval).
- Drive medical strategy and medical execution (real-world data generation, KOL development, publications, medical education, advocacy).
- Own commercial launch strategy and preparation.
- Lead project management; present regulator updates to Executive Management.
- Foster a culture of collaboration, excellence, and execution; maintain biopharmaceutical industry relationships; perform other duties as needed.
Qualifications:
- Bachelor’s degree in business or related life sciences; advanced technical/business degree preferred.
- 10+ years project/operations experience in the pharmaceutical industry (preferred).
- Proven success leading complex programs meeting/exceeding strategic objectives.
- Ability connecting technical and commercial sides; deep understanding of drug development and interdependencies (clinical, CMC/PDTO, regulatory, medical affairs, commercial).
- Competencies: strong business acumen, executive presence, strategic leadership, innovative, skilled communicator, complex problem solving, financial modeling, results-driven, self-motivated, highly organized.
- Working conditions: periodic evening/weekend work; ~25% overnight travel; hybrid Chicago office (minimum 3 days/week).
Compensation/Benefits:
- Anticipated base salary range: $250,000–$310,000; eligibility for bonus and equity; also includes multiple paid time off benefits, health insurance options, and retirement benefits.
- Lead the cross-functional XP-8121 project team to deliver on-time work aligned with compliance and quality standards.
- Oversee clinical execution (pivotal Phase 3) and product development for pre-NDA and NDA filing, including scaling for commercial volumes.
- Manage regulatory submissions (IND amendments, NDA filing and approval).
- Drive medical strategy and medical execution (real-world data generation, KOL development, publications, medical education, advocacy).
- Own commercial launch strategy and preparation.
- Lead project management; present regulator updates to Executive Management.
- Foster a culture of collaboration, excellence, and execution; maintain biopharmaceutical industry relationships; perform other duties as needed.
Qualifications:
- Bachelor’s degree in business or related life sciences; advanced technical/business degree preferred.
- 10+ years project/operations experience in the pharmaceutical industry (preferred).
- Proven success leading complex programs meeting/exceeding strategic objectives.
- Ability connecting technical and commercial sides; deep understanding of drug development and interdependencies (clinical, CMC/PDTO, regulatory, medical affairs, commercial).
- Competencies: strong business acumen, executive presence, strategic leadership, innovative, skilled communicator, complex problem solving, financial modeling, results-driven, self-motivated, highly organized.
- Working conditions: periodic evening/weekend work; ~25% overnight travel; hybrid Chicago office (minimum 3 days/week).
Compensation/Benefits:
- Anticipated base salary range: $250,000–$310,000; eligibility for bonus and equity; also includes multiple paid time off benefits, health insurance options, and retirement benefits.