Job description
Title: Associate Director/ Director, Program Management
Status: 6-month contract
Location: Onsite in Lexington, and Watertown, MA
Compensation: $55-$75 depending on experience
Overview
Seeking an experienced Program Management contractor who will report to the Head of Portfolio and Commercial Strategy. The individual in this role will work cross-functionally to drive the successful advancement of key programs. They will integrate efforts across R&D, clinical development, regulatory affairs, manufacturing, operations and commercial to meet critical milestones to advance programs and the platform. They will utilize team leadership, communication, and relationship building skills, along with project management tools to create and manage integrated program strategy, timelines, and drive accountability for deliverables. They will have a deep understanding of early to late-stage clinical development, CMC, and manufacturing scale up. This role is office based, primarily in our Lexington, MA site but will also work with cross-functional team members in our Watertown, MA site.
Day to Day Responsibilities
Qualifications
Status: 6-month contract
Location: Onsite in Lexington, and Watertown, MA
Compensation: $55-$75 depending on experience
Overview
Seeking an experienced Program Management contractor who will report to the Head of Portfolio and Commercial Strategy. The individual in this role will work cross-functionally to drive the successful advancement of key programs. They will integrate efforts across R&D, clinical development, regulatory affairs, manufacturing, operations and commercial to meet critical milestones to advance programs and the platform. They will utilize team leadership, communication, and relationship building skills, along with project management tools to create and manage integrated program strategy, timelines, and drive accountability for deliverables. They will have a deep understanding of early to late-stage clinical development, CMC, and manufacturing scale up. This role is office based, primarily in our Lexington, MA site but will also work with cross-functional team members in our Watertown, MA site.
Day to Day Responsibilities
- Work closely with Program Lead and CMC Lead to develop and guide project strategies, set goals and facilitate team decision making for the program.
- Lead program management activities, including all aspects of operational planning and execution such as timeline and milestone development and tracking, program team meeting management/minutes, decision making support, portfolio management activities and internal reporting and communication.
- Efficiently and collaboratively drive execution of development plans with a sense of urgency, from early-stage development through manufacturing scale up.
- Facilitate sharing of key learnings, insights and data across teams to advance the platform; rapidly assess impact on platform and projects when new information becomes available.
- Proactively identify risks, gaps, and resource bottlenecks; drive scenario planning; develop and implement mitigation plans.
- Support strong cross-functional communication by building solid working relationships across the organization and with external partners (as needed).
- Partner with key R&D leaders and finance to facilitate budgeting, forecasting, and long range planning activities.
- Lead discussions with senior leadership and external partners on program strategy, plans and execution; present program progress at internal company meetings.
- Support implementation of new team models, structures and communication forums as business needs evolve
Qualifications
- Bachelor’s degree in life sciences, engineering or related field. Advanced degree (MS, PhD or MBA) preferred. PMP certification is a plus.
- Minimum 10 years' experience in biotech/pharmaceutical industry in relevant functional disciplines with a minimum of 5 years in program management with responsibilities from clinical through commercial stage programs.
- Strong knowledge and understanding of global drug product development including essential activities for all key functional areas, in addition to technical transfer, QbD, cGMP manufacturing, analytical development, process validation, regulatory filings, clinical and clinical development. Experience with IND and NDA filings is preferred.
- Excellent project management and business operations skills, including utilizing Smartsheets, MS project and relevant tools to create project plans, with track record of managing projects on time and budget
- Demonstrated ability to work in ambiguous/changing conditions and understand complex projects with multiple inputs, outputs, and variables; great attention to detail
- Proven relationship building skills including the gravitas necessary to push and pull information
- Excellent communication skills (interpersonal, verbal and written) including an ability to communicate complex issues simply and crisply
- Ability to work independently in a fast-paced, innovative, results-driven environment while remaining flexible, proactive, resourceful, and efficient
- Ability to create and foster effective relationships, motivate others, influence without authority, and collaborate at multiple organizational levels.
- Excellent analytical skills in problem-solving and ability to adapt to changing priorities and deadlines
- Track record of achievement through teamwork
- Experience working on grant-funded development programs (NIH, NIDA, BMGF, DOD, etc.) is a plus