Product Development Team Lead
The Product Development Team Leader (PDTL) will manage the strategic direction and content of one or more key programs including: product life cycle planning; internal and external project communication; cross-functional integration and alignment; partnership management, and achievement of corporate and program goals. Using collaboration and influencing skills, the PDTL guides the product development team in evaluating appropriate alternatives and options, ensuring the team is aligned with key stakeholders. Primary responsibilities include:
- Leadership and management of all aspects of complex, global development programs, including those focused on multiple indications, from the end of lead identification stage through post-commercialization. Maximizing alignment, cooperation, input, decision making, commitment and synergy of product development team members to ensure their technical contributions meet/exceed program and commercial portfolio objectives. Integration of clinical/regulatory/manufacturing strategy into global product development strategy. Defining product development value points across the product development lifecycle. Prioritize and negotiate with internal stakeholders the required resources, including FTE’s, variable, and external resources. Fiscal responsibility for the program budget. Coordinate and manage team activities tailored to address the specific needs of individual programs while identifying innovative approaches to both increase the speed with which therapies can get to market while enhancing the value of programs as assessed by alignment with Target Product Profiles (TPPs). Work with the Operating Committee and Senior Leadership Team to define and implement best practices and balance resources across the development portfolio. Identify and review project issues and facilitate conflict resolution. Support the formation and execution of the company business strategy, licensing activities, and portfolio management. Stay abreast on PDT best practices and changing trends in a matrix organization. Promote a team culture and ensure the Product Development Team and other key contributors operate within miRagen’s mission and values. Effective alliance management with all development partners.
Qualifications and Required Skills
- A PhD, MBA or other advanced degree with a minimum 10 years of comprehensive drug product development experience. Oncology drug development experience preferred. Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe. Demonstrated accountability for delivery on complex development plans. Ability to understand and communicate risks, as well as develop and execute contingency plans. Demonstrated success as a PDTL in a matrix management environment. Ability to inspire transformative thinking and motivate employees to achieve quality-based deliverables. Ability to think creatively, develop and provide innovative ideas or alternatives that create value, including seeking new information and external insights, and execute them in a fast-paced environment. Ability to manage ambiguity and make sound scientific and business decisions with limited information. Proven ability to work effectively with cross-functional stakeholders in a complex, changing, environment. Skilled influential leader and manager. Line management experience preferred. Experience presenting data to regulatory agencies and advisory committee. Ability to think creatively and develop and execute in a fast-paced environment. Detail oriented with exceptional organizational skills. Effective communicator with strong verbal and written skills. Ability to identify issues, analyze situations and provide effective solutions. Solid understanding of the clinical development process. Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP. 10% - 25% travel required..