Director Product Development
Job Summary
The Director of Product Development is a supervisory role responsible for the oversight, timely execution and management of all internal and external development projects starting from project initiation through FDA approval and transfer to the commercial manufacturing site, if applicable. Additionally, this position is responsible for the oversight and training of employees at all junior levels within the Product Development organization.
Responsibilities
•Oversee portfolio projects through all phases of development including diligence, planning, API selection, legal assessments, literature reviews, execution, FDA filing, approval, and successful transfer to commercial sites•Oversee the timely development of drug product formulations and manufacturing processes which meet FDA stability and bioequivalence requirements and are capable of being produced at commercial scale•Oversee the external team to advance formulation development, process development, process characterization, technology transfer, and regulatory authoring of development projects within the defined timelines•Oversee the design and execution of detailed experiments using risk assessments, appropriate target product profiles, QbD principles, and process characterization/modeling techniques to develop and understand development processes, whether internally or externally developed•Support authoring and review of regulatory submission documents and deficiency responses•Manage resources to ensure timely completion of projects within budget, including oversight of external partners•Collaborate with other R&D scientific leaders to ensure project specific requirements are met•Provide guidance and advice in cross-functional meetings•Work with external partners and provide guidance and assistance as needed•Oversee the entire clinical plan for each project, including studies needed, trial design, number of participants, etc.•Oversee the clinical staff to ensure timely conduct of clinical trials and compliance to study protocol, applicable guidances and SOPs•Review statements of work (SOW), payment terms and milestones•Reviews clinical study protocols, reports and summary tables for ANDA/ IND/NDA/ filings •Coordinate alignment on the final clinical study protocol for execution•Oversee the execution of study timelines •Oversee the receipt of final study reports in FDA compliant format and help resolve any issues identified, as needed•Oversee the clinical trial permission application process to foreign regulatory agencies and assist in export of investigational products to clinical CROs in foreign countries •Oversee multidisciplinary activities for successful clinical trial applications and conduct of clinical studies• Assist in monitoring clinical studies onsite or remotely and/or appoint external monitors to monitor study conduct on-site•Review and approval monitoring reports •Oversee the CRO selection process•Lead, develop and mentor scientists in support of the company’s goals for the pipeline portfolio•Lead the PD function to develop and implement strategies for driving programs towards key milestones and objectives•Prepare, review and approve performance reviews, performance improvement plans, disciplinary actions, job descriptions, training plans, and employee development plans•Set and assess department and individual review goals•Oversee training and personal development programs for department employees•Influence, motivate, and energize employees at all levels•Maintain expertise in product development and regulatory requirements •Interact with key stakeholders (Operations, Quality, Commercial, Analytical, Clinical, Regulatory, External Partners, etc.) to define and optimize business processes maximizing agility and consistency•Participate with the leadership team in charting the future direction and growth of the organization, hiring, resourcing, budget, etc.• Other duties as assigned
Experience
• Master's degree required•8 plus years in pharmaceutical product development in a supervisory/management role
Other Skills
•Strong leadership and management skills, including mentorship of colleagues•Strong analytical and problem-solving skills•Strong organizational skills•A high level of integrity•Ability to work independently and in a team environment•Ability to successfully negotiate and drive change around processes•Ability to drive process improvement initiatives – must be able to understand and evaluate current processes and make recommendations for improvements•A history of demonstrating successful negotiation and relationship management skills•Ability to work well with a variety of personality types, to motivate those you interact with and take control of processes/situations as needed while maintaining a customer-service focused attitude•A strategic thinker, planner, and implementer•Effective verbal and written communication•Strong scientific and regulatory understanding of product development for ANDA/NDA FDA submissions including scientific writing skills and documentation review skills•Ability to collaborate effectively cross-functionally and with external partners•Proficient with pharmaceutical industry business processes: change control, deviations, SOPs, protocols, reports, etc.•Working knowledge of statistics and data analysis•Proficient in Microsoft Office and applicable statistical software
