Senior Director Product Development

Senior Director Product Development

I am currently working a well-established and global pharmaceutical company who have a robust portfolio which includes specialty products for multiple therapeutic areas including urology, oncology and dermatology.

They are a leading player for topical and injectable products

with numerous FDA-approved products, they have earned a global reputation for their strict standards, expertise in manufacturing and proven record in regulatory and clinical development

They are currently seeking a Senior Director of New Product Development who will lead the full life cycle from early stage fillings to commercial launch, reporting into the SVP of Tech Ops.

This position involves creating and implementing scientific strategies, focusing on formulation and process development (505b2).

It serves as the primary scientific contact for business partners and industry experts relevant to the company's interests.

The role is crucial in shaping the company's product strategies and leveraging long-acting injectable technology to drive growth.

Key Responsibilities

• Act as a key member of the product development leadership team and a technical and scientific advisor to the Analytical, Clinical, Regulatory, Legal, MS&T, EPMO, Commercial, Quality, Finance, and Business Development teams.
• Develop comprehensive long-term plans for formulation and process development in collaboration with other departments to support company growth objectives.
• Translate strategic goals into detailed operational project plans.
• Oversee, prioritize, and manage projects from early stages through clinical studies and regulatory submission, ensuring timely and resource-efficient delivery.
• Promote a culture of innovation to develop new, effective, and patentable technologies and formulations.
• Recruit, train, develop, assess, and manage staff according to company policies and relevant regulations, in collaboration with Human Resources.
• Enhance communication and collaboration across the organization.
• Ensure projects are executed in an organized, timely, and cost-effective manner, meeting budget, timeline, and quality requirements.
• Set and maintain high performance standards for the team, encouraging innovation and adherence to compliance.
• Make informed decisions on internal and external development paths for regulatory submissions and approvals, and oversee the selection and management of CMOs and CROs.
• Collaborate with the IP team to protect and expand the company's intellectual property.
• Uphold compliance with quality, safety, confidentiality, and corporate integrity standards and policies.
• Develop and manage budgets for formulation and process development areas, ensuring resource allocation and expenditure monitoring.

Qualifications and Skills

• Preferred : Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related field.
• Over twelve years of relevant experience in the pharmaceutical or biotech industry and More than eight of management experience.
• Proven experience leading a substantial research team and collaborating closely with early-stage, analytical, device, manufacturing, and quality functions within a plant environment.
• Extensive knowledge of injectable drug delivery systems, controlled-release technologies, biodegradable polymers, aseptic processing, the 505(b)(2) regulatory pathway, and cGMP regulations.
• Significant experience in the formulation of long-acting or extended-release parenteral products, including formulation development using Quality by Design (QBD) principles.
• Strong scientific project management abilities to set strategic goals and effectively prioritize, plan, delegate, and evaluate project deliverables.
• Exceptional verbal and written communication and presentation skills, with the capacity to convey complex scientific and technical information clearly and accessibly.
• Excellent leadership qualities; capable of fostering a transparent, collaborative, and innovative working environment.
• This position will provide relocation servieces with a lump sum upfront (which is agreed on)

Apply today to learn more or reach out directly with your resume to [email protected]