Director Product Development
Apply NowCompany: LANNETT CO INC
Location: Feasterville Trevose, PA 19053
Description:
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
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