Senior Program Manager
The Senior Program Manager has responsibility for managing a combination product development program from initial project approval through IND submission. This position, informed by a technical background, is responsible for providing strong leadership to assure development of a safe, pure, and stable drug constituent of a combination product. The candidate for the position has a strong technical background in analytical, regulatory and quality issues related to drug product development, with strong project management skills. The Senior Program Manager will lead, enable, or consult in the development and execution of combination product development and regulatory submissions by working with a cross-functional team of internal and external partners. This work will include managing drug product analytical work to ensure that it is phase-appropriate to meet the demands of development, while meeting all regulatory requirements. The position requires close cross-functional collaboration with internal partners and external contract manufacturing sites. Very strong oral and written communication skills are required. Knowledge of parenteral drug products, combination products, regulatory submissions, technical requirements, and analytical methods are highly desirable for this position. This position reports to the Senior Director, Program Management.
- Responsible for overall project knowledge, and coordination of input from key technical groups, to manage project according to plan and to manage timeline for submission of IND.
- Manages project with a cross-functional team to ensure appropriate pharmaceutical development and testing, risk management activities, documentation, and contributions to regulatory submissions.
- Provides strong scientific leadership to assure a safe, pure, and stable drug constituent of a combination product.
- Ensures that drug product meets requirements and expectations for quality, compliance to standards, and regulatory submissions.
- Establishes and implements project management processes and methodologies to manage IND submission timeline.
- Plans tasks and interacts effectively with internal departments (QA, Regulatory Affairs, Manufacturing and Operations, Clinical, etc.) to achieve project plans.
- Establishes and maintains close working relationships with development consultants and external labs.
- Assesses reports and data, interprets findings, and draws authoritative conclusions.
- Authors and/or reviews CMC regulatory documents, specifications, development protocols, validation protocols, and product development reports ensuring scientific integrity and compliance with all regulatory requirements.
- Performs other related duties as assigned.
Education and Experience Requirements
- BS degree or higher in biology, biochemistry, chemistry, or chemical engineering.
- BS with 8 years, MS with 6 years or PhD with 3 years of experience required.
- Technical expertise in sterile parenteral drug product development phases.
- In-depth knowledge of relevant regulations and experience in authoring relevant sections in regulatory submissions.
- Experience in collaboration with external analytical labs and management of those relationships.
- Well versed in GMP regulations and possess experience with analytical methods.
- Knowledge of combination products or drug development processes and interactions between device and drug components in combination devices.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, and with external partners and vendors.
- Demonstrated capability to operate in an interdisciplinary environment.
- Possesses strong written and verbal communication skills.
- Occasional travel may be required.
Skills and Abilities
- Excellent organizational, interpersonal, and communication skills.
- Ability to multi-task and productively manage complex situations involving cross functional teams.
- Passion for working in a challenging environment and creating innovative, valuable, and high-quality products.
- High degree of personal responsibility, integrity and respect for others, with similar expectations of colleagues and business partners.
- High level of emotional intelligence and professionalism in decision-making.
- Ability to identify and prioritize critical activities.
- Demonstrated leadership capabilities, flexibility, and ability to operate in a fast-paced and changing environment.
- Strong work ethic, problem solving skills, and a hands-on approach.
- Ability to confer with others to reach resolution acceptable to all parties involved.
scPharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.