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Sr. Director, Program and Project Management (PPM) - Durham

Company: Intarcia Therapeutics, Inc.
Location: Durham
Posted on: September 15, 2019

Job Description:

Intarcia is rethinking medicine with the potential to unlock significant change in the way serious chronic diseases or conditions are treated S-starting first with Type 2 Diabetes, and then, obesity and HIV. To date, the company has raised more than $1.8B in capital through creative financing and partnerships - including our collaboration with the Bill and Melinda Gates Foundation for HIV prevention in Sub-Saharan Africa. Intarcia headquarters are in Boston, MA with manufacturing and R&D locations respectively in Hayward, CA and Durham, NC.Intarcia is committed to developing innovative therapies utilizing the Medici Drug Delivery System which is designed to bridge technology and medicine to transform therapeutic categories. The matchstick-sized osmotic mini-pump is subdermally placed and delivers a continuous flow of medication over the course of months, working with the patient's own body. This approach is designed to support adherence and allow individuals to focus on more fully living their lives.The Sr.Director,Project and Program Management will play a significant role in ensuring the successful development of a combination drug/device product for HIV pre-exposure prophylaxis (PrEP). As this program is done in collaboration with an outside organization, the position holder will have regular interactions with this business partner. This position requires extensive knowledge in product development - with a special emphasis on Preclinical Development, CMC, and Clinical Development. Additional experience in device development is preferred. The candidate will work closely with experts in all these groups. The Sr. Director, PMO will lead teams in achieving project goals using timelines and documented plans to track risks/issues/action items; they will also provide timely project updates to management and escalate critical decisions when necessary. In addition to the key role on the HIV PrEP program, the Sr. Director will work closely with Intarcia's Discovery and Translational Medicine team and the Project Management Organization to track and manage Intarcia's other early stage pipeline projects.Duties and Responsibilities:Program/Project Management - PlanningFully considers Intarcia's business strategy during project planning, execution & control (considering functional strategy, -processes, -resources, ...)Ensures establishment and maintenance of a project strategy: develops, reviews and modifies (i.e. if significant assumptions have changed) strategy together with team. Presents and gets strategy approved at respective decision bodies within Intarcia and BMGFPlans for project execution according to project needs and functional capabilities -- elevates functional constraints to appropriate decision bodyProvides project resource need estimates to appropriate decision body: finance, human, equipment, capacityOrganizes project core team to operate effective and efficientlySpecifies Roles & Responsibilities for Core Team Members (CTMs) for current program / projectEstablishes and maintains overall project plan and documentationDevelops and maintains Integrated Program Plans (IPP) for Corporate ProgramsDrives risk management process: identification of uncertainties and planning for moving project risk towards opportunityEnsures alignment on definition and setting of project milestonesPlans and maintains project budget/forecast and business model estimates. Prepares new financial estimates upon project changes causing spending/income changes exceeding specified threshold.Maintains all documentation needed for collaboration with BMGF and works closely with BMGF to maintain project and documentation alignmentWorks with Intarcia senior management to ensure all early stage pipeline projects have IPPs.(Program/Project) Management - ExecutionAccountable for overall HIV PrEP project results and plans for other early stage pipeline projectsEstablishes and manages (cross)-functional teams (e.g. project core team) as requiredEnsures execution and completion of project tasks by assigning accountable individuals: sets goals, deliverables and due datesProvides timely input/updates to the project teamAccountable for timely completion and quality of required progress reportsEstablishes and maintains project communication planPresents project requirements to respective stakeholder groupsMonitors project progress according to project plan. Proactively escalates issues if requiredChange Control: Documents all project changes against original assumptions and specsDrives timely completion of deliverables by monitoring accountable Core Team MemberEvaluates output of task deliverables in the context of the overall project objectivesEnsures availability of information disclosure agreements for collaboration with outside partiesProcess ManagementAdheres to PMO process and ensures that project decisions are made appropriatelyCommunicates on regular basis to respective governance body and partners about program/project issues and progress, timelines, upcoming resource needsEscalates potential resource conflicts with other projects to decision bodiesEnsures timely completion of project documentation needed by Intarcia and collaborators and assigned to PMOQualifications:Product Development & Technical SkillsExperience and knowledge in the following: GMP Development of Drugs, Biologics or Combination products, Development of Medical Device,Excellent knowledge of scope and deliverables of relevant product development phases.Experience in assessing validity of overall project deliverables and strategyPreferred experience in having successfully managed the progression of a drug from pre-clinical through various stages of clinical development and ideally through approval.Experience, acumen, and demonstrated excellent teamwork and communication skills to enable productive collaborations with multiple stakeholders, internal and external, to advance a projectManagement SkillsPersonal accountability for resultsAble to deal with ambiguityPro-activeDelivers on timeExcellent communication skills: for discussions, presentation and moderation with senior management, business management & cross-functionalAble to lead and align team members to achieve project goalsAble to distill complex issues and to provide concise summariesCritical thinking and problem solvingPlans, documents and organizes effectivelyExperience in driving and completing assigned tasksProcess Management SkillsAware of interdependencies and interfaces between departments of a Development organizationAble to identify gaps within business processes - drives resolutionProfessional Experience8 years Project Management experience in Biotech/Biopharma environment required10 years product development experience requiredPMP or equivalent certification preferredLife sciences degree with post-graduate training preferredAbout Intarcia:Intarcia Therapeutics, Inc. is a biotechnology company dedicated to redesigning the prevention, treatment and experience of chronic diseases including diabetes, obesity and HIV. As an organization, we are driven by a desire to create meaningful change in both business and health, rethinking how prescription medicine is delivered. Our dedicated team operates with a "No Analog" mindset-continually pushing boundaries, navigating new terrain and unleashing fresh thinking. It's all part of Intarcia's commitment to enable better outcomes and create impact.The Intarcia Medici Drug Delivery System was developed over a 20-year span in collaboration with a diverse, forward-thinking team of scientists and entrepreneurs with a goal of bridging technology and medicine to transform therapeutic categories. Based on human behavior, the Medici System is intended to relieve the burden and adherence concerns of chronic therapy by delivering prescribed medicines for six months at a time - or potentially longer. Intarcia is also investigating multiple new therapies, including combination therapies for chronic diseases leveraging the convergence of novel medicines from Intarcia's pipeline with the proprietary Medici System.For more information visit www.intarcia.com.(No relocation/Local candidates only)

Keywords: Intarcia Therapeutics, Inc., Durham , Sr. Director, Program and Project Management (PPM) - Durham, Executive , Durham, North Carolina

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