Associate Director, Nonclinical Development Program Management & Strategic Operations (Late-Stage Development)

Scorpion Therapeutics; Boston (MA); On-site; USD 150,000 - 230,000; Full time

Job summary

Scorpion Therapeutics in Boston, MA seeks an Associate Director, Preclinical Sciences, Program Management and Strategic Operations to design and execute multiple complex development and regulatory plans for the company’s pipeline. You will align with disease-area objectives and budget constraints while driving cross-functional collaboration with Project Leaders and CRO partners.

Responsibilities include creating integrated project plans, tracking milestones, reporting to Senior Management, and

Qualifications

• Bachelor’s Degree required.
• Typically 10 years of work experience or equivalent.
• Broad knowledge of GLP regulations and preclinical regulatory submissions.

Responsibilities

• Establish project team norms and measure performance.
• Independently lead teams for critical development projects.
• Review plans, budgets, and logistics; assist with risk scenarios.
• Coordinate with CRO partners on scheduling and reporting of preclinical deliverables.
• Summarize program progress and risk/opportunity assessments for management.
• Mentor staff and manage direct reports.
• Serve as study representative on preclinical studies.

Skills

GLP regulations

Full life-cycle drug development

Written and oral communication

Influence decision-making

Project leadership

Budgeting and forecasting

Education

Bachelor’s Degree

Job description

General Summary

• The Associate Director, Preclinical Sciences, Program Management and Strategic Operations will integrate, create, and execute multiple complex pharmaceutical development/regulatory plans.
• Collaborates with Project Leaders, cross-functional teams, and CRO partners to develop and maintain integrated project plans to ensure deliverables are executed in alignment with disease area and project objectives and within budget.
• Provides comprehensive communication including status reporting, risk management, and escalation to cross-functional stakeholders and Senior Management.

Key Duties & Responsibilities

• Establish project team operating norms and measure performance.
• Independently lead teams for critical development projects.
• Review/compile plans, budgets, and logistics; assist with scenario planning including assumptions and risks.
• Work with CRO partners on scheduling and reporting of preclinical deliverables.
• Summarize program progress, timeline updates, and risk/opportunity assessments for management.
• Track high-level program deliverables; pursue innovative ways to stay current (operations practices/advanced technology).
• Lead and support worldwide nonclinical regulatory submissions.
• Forecast and maintain program budget; oversee budgets for direct reports.
• Mentor staff; motivate personnel and resolve conflicts.
• Craft goals for direct reports (with supervisor) and align with corporate goals.
• Mentor subordinate managers and high-level professionals.
• Serve as study representative on preclinical studies.
• Manage one or more direct reports.

Required Education

• Bachelor’s Degree.

Required Experience

• Typically 10 years of work experience or equivalent combination of education and experience.

Required Knowledge/Skills

• Broad, comprehensive knowledge of GLP regulations.
• Comprehensive knowledge of full life-cycle pharmaceutical drug discovery and development across multiple preclinical disciplines (e.g., research, DMPK, toxicology, biomarkers).
• Extensive understanding of preclinical regulatory submissions documentation and process.
• Excellent written and oral communication skills.
• Ability to influence decision-making and outcomes across teams.

Preferred Skills

• Knowledge/experience in outsourced preclinical model.
• Preclinical Regulatory experience with IND/CTA and global marketing submissions.