Director, Pharmaceutical Sciences Program Leadership

Scorpion Therapeutics; Boston (MA); On-site; USD 250,000 - 360,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced pharmaceutical development leader to drive CMC strategy across multiple programs, leading cross-functional teams and influencing global partners.

You will mentor staff, shape regulatory strategies, and push state-of-the-art scientific standards to accelerate development and ensure quality deliverables for complex biologics and small-molecule programs.

Qualifications

• BS/MS/PhD with extensive pharma development experience
• Deep knowledge of lab methods, instrumentation, process development, and statistics
• Experience with regulatory affairs and global submissions

Responsibilities

• Lead development strategy and plans for multiple complex programs
• Provide strategic scientific leadership for global CMC teams
• Identify and mitigate project risks; mentor staff across groups
• Represent CMC in cross-divisional governance and initiatives
• Drive innovation and state-of-the-art technical standards
• Build cross-functional/global teams and networks for development

Skills

Pharma development expertise

External industry advocacy

DMPK

Pharmacology

Toxicology

cGMP knowledge

ICH guidelines

Regulatory interactions

Regulatory submissions

Leadership

Risk management

Stakeholder communication

Documentation

CMC perspective

Resource management

Education

BS + 18 years

MS + 16 years

PhD + 10 years

Job description

Objective / Purpose

• Engage others by inspiring commitment; collaborate through influencing relationships, mobilize high performance, anticipate group needs, and develop capabilities aligned to those needs; champion change and mentor junior staff across technical and Takeda competencies.

Responsibilities

• Independently lead development of strategy and plans for multiple complex programs.
• Lead and influence functional/divisional strategy, operations, and innovation.
• Provide strategic scientific leadership and program management for multiple global CMC development teams.
• Identify, mitigate, and communicate project/program risks; advance not only led teams but others facing challenges.
• Serve as functional expert in divisional and cross-divisional initiatives.
• Represent CMC on cross-divisional governance/development teams; provide strategy and accountability for CMC deliverables.
• Provide scientific leadership and innovation in pharmaceutical R&D; build cross-functional/global teams.
• Mentor department members; act as an internal consultant to Pharmaceutical Sciences.
• Develop departmental capabilities by assessing the business and anticipating changes.
• Represent Pharmaceutical Sciences in cross-divisional/corporate/global initiatives; cultivate networks with affiliates/alliance partners.
• Inspire commitment via meetings, writing, and presentations; develop business cases that motivate action.
• Ensure state-of-the-art technical/scientific standards; identify/evaluate/ recommend/ negotiate novel solutions.
• Critically review external technical/scientific reports and coordinate Takeda-sponsored work.

Qualifications

• BS + 18 years; MS + 16 years; PhD + 10 years.
• Expert knowledge of pharmaceutical development (laboratory techniques, instrumentation, problem solving, process engineering/manufacturing development, and experimental statistics) and contributions to external industry/advocacy groups.
• Knowledge of allied fields (e.g., chemical/analytical/physical chemistry, pharmaceutics, QA and/or regulatory affairs); advanced DMPK, Pharmacology, and Toxicology.
• Extensive cGMP and ICH guideline knowledge; knowledge of regulations/compendial requirements and regulatory agency interactions.
• Experience with global regulatory submission requirements and processes.

Skills/Competencies

• Leadership for complex multidisciplinary programs.
• Risk management (technical, budgetary, schedule) and CMC technology/trend gap identification.
• Clear communication to stakeholders; concise documentation; represent CMC viewpoint.
• Resource management (people, information, technologies, time, capital).