About the Role:Recommends a vision and leads the strategic direction of the pharmaceutical development function; overseeing formulation, drug product development, manufacturing readiness, and CMC innovation across the portfolio. Ensures efficient progression of assets from early development through commercialization while aligning with corporate goals, regulatory requirements, and industry trends. Serves as a key advisor to executive leadership on development strategy, manufacturing technologies, and portfolio decisions, while building organizational capabilities and developing future leaders.
Drives cross-functional initiatives and external collaborations, fostering innovation, operational excellence, and a strong patient-focused culture. Partners with leaders across Clinical, Regulatory, Operations, Quality, Safety, and Commercial to ensure CMC strategies, risks, and mitigation plans are communicated in support of global filings and approvals.Your Contributions (include, but are not limited to):Establish and execute the long-term vision, strategy, and operating model for Pharmaceutical Development, ensuring alignment with portfolio objectives and corporate strategyProvide strategic leadership for formulation development, drug product process development, technology transfer, process validation, manufacturing readiness, and lifecycle management across development programsServe as a key member of the Technical Operations leadership teams, influencing portfolio decisions, resource allocation, risk mitigation strategies, and investment prioritiesDrive innovation through evaluation and implementation of emerging formulation technologies, advanced manufacturing approaches, digital tools, and external scientific partnershipsLead organization-wide initiatives to enhance Pharmaceutical Development capabilities, operational excellence, scalability, and regulatory readinessProvide executive oversight for development and commercialization strategies for sterile, parenteral, combination product, and other advanced dosage form programsPartner with Regulatory Affairs, Quality, Technical Operations, Clinical Development, Program Leadership, Supply Chain, and Commercial organizations to develop and drive integrated development and execution strategiesAnticipate and address complex scientific, technical, operational, and business challenges with broad organizational impactBuild and maintain strategic relationships with CDMOs, technology partners, regulatory agencies, academic institutions, and industry expertsRepresent the company externally through scientific publications, conference presentations, industry forums, advisory boards, and strategic collaborationsDevelop organizational talent through coaching, succession planning, leadership development, and creation of a high-performing and inclusive cultureEstablish enterprise metrics and performance frameworks that ensure execution excellence, accountability, and continuous improvement across the Pharmaceutical Development functionRequirements:Bachelor's degree in Biological, Chemical, or Pharmaceutical sciences/engineering or related field AND 16+ years of applicable experience ORMaster's degree in Biological, Chemical, or Pharmaceutical sciences/engineering or related field AND 14+ years of applicable experience ORPh.D. degree in Biological, Chemical, or Pharmaceutical sciences/engineering or related field AND 12+ years of applicable experienceRecognized internally and externally as a leader in pharmaceutical development, formulation sciences, and drug product developmentActs as a "trusted advisor" across the company and possesses industry-leading knowledgeDemonstrated success developing and executing long-term functional strategies that drive portfolio advancement and organizational performanceExtensive expertise in formulation development, process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readinessProven ability to influence executive leadership and shape decisions affecting portfolio strategy, resource allocation, and organizational prioritiesDeep understanding of global regulatory expectations, quality systems, cGMP requirements, and evolving industry trendsStrong business acumen with demonstrated ability to balance scientific innovation, operational execution, risk management, and investment prioritiesExperience leading large, complex, cross-functional organizations and developing high-performing leaders and teamsDemonstrated success managing strategic external partnerships, CDMOs, technology providers, and key industry stakeholdersExceptional communication, negotiation, and influencing skills, including interactions with executive leadership, regulatory agencies, external partners, and scientific organizationsTrack record of driving transformational change, organizational capability building, and continuous improvement initiativesRecognized ability to anticipate future business and industry trends and translate them into actionable strategic plansDemonstrated commitment to fostering innovation, developing talent, and creating a culture aligned with the company's mission and values
Executive Director, Pharmaceutical Development (Solid Orals) in san diego at Unknown Company
This position is listed as full time and onsite.