Director, Strategic Development Consulting (Remote US)

Company: PPD
Location: Austin
Posted on: June 24, 2022

Job Description:

About PPDJob DescriptionPPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.About The PositionThe Director, Strategic Development Consulting is responsible for developing and implementing full product development plans from preclinical development through post-approval. They work in collaboration with and on behalf of clients to design and execute product development programs on both local and global levels. Applies firsthand knowledge of state-of-the-art clinical strategies and biostatistical science to a range of client development programs for small molecules, vaccines, biologics, and biosimilars. This includes managing internal and external relationships and assembling and managing joint development teams aimed at supporting full product development programs. This position acts as an executive sponsor for programs and ensures effective communication with client leadership teams and PPD stakeholders.About Our Culture, Career Advancement And BenefitsAt PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.Job Description

• Provides strategic advice to internal and external clients to determine the most appropriate product development strategy for their products. Provides project specific strategy, technical expertise and coordination oversight for key client's projects.
• Serves as the executive contact for key clients for all issues. Ensures quality performance for key/managed projects.
• Develop key partnership strategies incorporating program management
• Coordinate strategic planning and track tactical execution activities in strategic relationships; identify opportunities/gaps in execution to maximize effective delivery of asset goals
• Works to develop new partnership agreements and expand opportunities with current partners
• Develop sponsor-specific relationship and communication charters for full asset development engagements
• Manage support infrastructure and provide direct support for winning full product development programs and consulting services contracts
• Oversees project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget.
• Collaborates with business development and senior management to secure new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation.
• Actively engages in business development activities focusing on the expansion of the department's global footprint.
• Delivers solid business plans that incorporate clear goals, objectives and tangible activities that lead to success.
• Oversees the development and implementation of systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics and other key performance indicators. The ideal candidate will have experience developing strategies to support first-time-in-human studies through marketing application and leading activities related to planning and executing development programs throughout the entire product lifecycle. They will also have experience leading development of strategic documents (integrated development plans, clinical development plans, life cycle plans, target product profiles) and managing alliances, sponsor partnerships, and complex projects and portfolios.Job QualificationEducation And Experience
  • An advanced degree (PhD, MD, MSc, MPH, PharmD) is preferred.
  • 12+ years in the pharmaceutical/biotech industry, with significant regulatory experience in different Therapeutic Areas.
  • 7+ years of drug development experience, including experience with non-clinical, clinical drug development and understanding of regulatory environment
  • Or an equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills and abilities listed below Knowledge, Skills & Abilities
    • Ability to cultivate cross-functional collaborations within a matrix team environment
    • Strong decision-making and analytical skills are required
    • Excellent communication and influencing skills
    • Thorough understanding of overall biologic/pharmaceutical product development process, from pre-IND through post-marketing, including all stages of development and all functional roles
    • Solid understanding of core cross-functional concepts (e.g., preclinical, translational medicine, CMC) and major requirements at different development stages
    • Working knowledge of the biological sciences with technical, scientific or medical expertise in one or more functional areas involved in pharmaceutical/biologic product development
    • Knowledge of commercial valuation, product life cycle planning, pricing and health economics
    • Excellent organizational skills, professional conduct, dedicated, and detail-orientated
    • Flexibility to travel domestically and internationally
    • Proven ability to work independently and effectively on multiple tasks in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior management. Below Is Listed The Working Environment/requirements For This RolePPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
      • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
      • Able to work upright and stationary for typical working hours.
      • Ability to use and learn standard office equipment and technology with proficiency.
      • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
      • May require travel as needed
      • Employees hired in this role may be assigned to a US government contract and if so would be subject to COVID-19 vaccination and reporting requirements PPD Defining Principles
        • We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing - We are one PPDIf you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we would love to hear from you.

Keywords: PPD, Austin , Director, Strategic Development Consulting (Remote US), Executive , Austin, Texas