Sr Director New Product Development

Tulsa, OK, United States

Description

Purpose and ScopeDirect, lead and monitor the product development lifecycle from Early Stageexit through regulatory filing and product launch. This position isresponsible for the development of scientific plans, including theformulation and process development functions. This position functions as thescientific liaison to business partners and thought leaders in areas ofinterest to the company. This role will provide critical input to thecompany's new product strategies and application of its long-actingInjectable technology to meet the growth goals of the company.Essential Duties & ResponsibilitiesServe as a product development leadership team member and act as an internaltechnical and scientific partner to the Analytical, Clinical,Regulatory, Legal, MS&T, EPMO, Commercial, Quality, Finance,and Business Development functions.Create long-range development plans for the formulation and processdevelopment functions in conjunction with other departments to meet thecompany's growth goals.Define goals per the company strategy and translate these goals intooperational project plans.Coordinate, prioritize, and manage pipeline projects from early stage exitthrough commencement of clinical studies and regulatory filing, ensuringthat timelines, resources, and priorities for pipeline projects aredelivered promptly.Nurture a culture of innovation, ensuring that technology and formulationsachieve novel, effective, and patentable inventions.Hire, train, develop, evaluate, and manage staff as necessary, inaccordance with company policies and federal/state regulations, with inputfrom the Human Resources department.Foster a strong sense of communication and collaboration within theorganization.Ensure projects are managed in a structured, organized, and cost-efficientmanner to meet timelines, budgets, and quality standards.Set appropriate goals and performance standards for the team and provide anatmosphere that fosters innovation and compliance.Participate in decisions regarding internal or external development paths forregulatory filings and approval. Assist in the selection and management ofCMO's and CRO's.Work collaboratively with the IP team to enhance and expand the company'sassets.Foster and maintain compliance expectations with quality, safety,confidentiality, and corporate integrity standards/policies.Develop a budget for the formulation and process development functionalareas, manage and allocate resources, and monitor expenditures.Stay abreast of technical knowledge and trends in the controlled-releaseinjectable drug delivery sector.Ensure that all regulatory and internal policies are followed.Perform other related duties as assigned.

Knowledge, Skills & AbilitiesMust have experience managing a sizeable research team and working closelywith early stage, analytical, device, manufacturing and qualityfunctions in a plant environment.Broad knowledge of injectable drug delivery platforms, controlled-releasetechnologies, biodegradable polymers, aseptic processing,505(b)(2) regulatory pathway, and cGMP regulations highly desirable.Demonstrated experience in formulation of long acting / extended releaseparental products, including formulation development utilizing Quality byDesign (QBD).Demonstrated scientific project management skills to establish strategic goalsand to prioritize, plan, delegate, and evaluate deliverables.Excellent verbal and written communication and presentation skills with theability to communicate scientific/technical in an easy to understand manner.Strong leadership skills; creating a dynamic environment that fosterstransparency, collaboration, and innovative thinking.Excellent problem-solving skills; ability to analyze complex sets of dataand make sound decisions and recommendations in a timely manner.Strong intellectual capabilities; conceptualizing and developing new andcomplex injectable technologies.Entrepreneurial mindset; can identify opportunities and execute.Self-motivated and proactive.Excellent coach and mentor; passion for developing high-performing teams.

Core ValuesThe Sr Director New Product Development is expected to operate within theframework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, successes, and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company's success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task.Education & ExperiencePh.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry,Biochemistry, Chemical Engineering, or a related field is preferred.Twelve plus years of related pharmaceutical or biotech experience.Ten plus years of management experience.Proven experience in new and late stage product development programs incomplex injectable products and branded pharmaceutical products.Working ConditionsWorking conditions are typical for an office environment.Laboratory and Manufacturing setting.Some travel may be required.Compensation and BenefitsAnnual Pay Range: $240,000 - $250,000Benefits information: https://www.tolmar.com/careers/employee-benefits

#J-18808-Ljbffr