US-MA, Associate Director / Director, Translational Research and Early Clinical (TREC) Global Program Management 1603134-MZ
Are you looking for a patient-focused company that will inspire you and support Associate Director, Global Project Management GI (Translational Research and Early Clinical)in our Boston office.
Provides project management and leadership to ensure cross-functional, cross-divisional project plans for early stage assets are in place that bridge the Research to Development stage. The TREC PM will drive the creation and execution Early Clinical Research Plans (ECRPs) to advance early development assets from Research to Early Proof-Of-Concept (EPOC), which is the first major clinical development decision point. Responsibilities include translating the cross-divisional, integrated asset strategy into an executable plan using innovative approaches to ensure rapid and effective decision-making to move the program forward.
The TREC PM works closely together with the Global Program Leader (GPL), Therapeutic Area Units (TAUs), Drug Discovery Units (DDUs), Translational Clinical Scientists, TREC Leadership and other R&D functions to ensure that the medical and scientific strategy is integrated into an operational plan.
This role may also lead key initiatives that have cross-functional impact and that are critical to the objectives of TREC, R&D and/or global business objectives.
Identifies and drives innovative process improvements for TREC with significant organizational impact. The TREC PM will take on, as needed, non-project responsibilities, which can include project management processes and systems which will help bridge innovation across programs and ensure budgets/timelines are aligned to support innovative thinking.
Lead the project planning efforts to IND submission and execution of early clinical studies, organize translational and clinical subteams in defining and implementing the asset strategy.
Responsible for coordinating teams to get ready for governance approvals.
Proactively identify and drive project and resource priorities that align with the program objectives.
Addresses and resolves project challenges, keeping leadership informed of critical considerations (e.g., resources, performance concerns). Provides clarity and direction in urgent or unexpected situations.
Establishes, communicates and executes plans resulting in achievement of project goals.
o Drives and manages the creation of project strategies and prepares/presents these strategies to key stakeholders and decision-makers
o Provides clear and targeted messaging to teams, translating corporate priorities into clear and meaningful team goals.
o Provides direction and obtains buy-in of all team members to integrated asset strategy.
o Identifies opportunities to accelerate the project execution where possible while maintaining high quality standards.
o Continuously and efficiently manage stakeholders at various levels and across functions.
o Responsible for collaborating with TAUs especially when projects are close to transitioning into late stage development
As a key member of GPT during the early clinical phase, the TREC PM will attend and facilitate team meetings. With input from the GPL, ensure agendas are appropriate to enable key discussions and decisions within the team.
Partners with the GPL to lead and manage cross-functional activities through IND and EPOC.
Proactively identify potential issues or obstacles and achieves resolution or plans contingencies and follow issues through to resolution ensuring that all GPT issues arrive at a singular conclusion or recommendation.
Manages timelines for assets from Discovery through EPOC transition and is accountable for reporting the progress of these timelines to various stakeholders.
Provides regular and ad-hoc project status reports.
Demonstrates professionalism by appropriate behaviors (e.g. able to identify and resolve conflict, maintains self-control, creates an environment of confidence and respect.)
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS
Bachelor s Degree in science or business-related field
Advanced scientific degree is strongly preferred
Detailed and in-depth knowledge of pharmaceutical industry with a focus on early drug development from preclinical through early clinical phase.
Substantial experience (7-10 years) on complex pharmaceutical project teams in a multi-disciplinary, global environment.
Proven leadership experience in managing matrix teams, influencing outcomes and key project decisions, and strategic problem-solving ability.
Competent about application of project management processes, tools, and techniques to meet project requirements.
Proven leadership skills for innovative thinking.
Substantial experience in intercultural cooperation.
Proven ability to communicate clearly and present key information objectively and collaborate effectively with management.
Demonstrated ability to clearly and concisely communicate/prepare presentations for management.
Knowledge and Skills
Project leadership and/or management skills for programs in the preclinical to early clinical development phase are required.
Knowledge of Therapeutic Area (clinical, regulatory guidance and study conduct) preferable.
Ability to articulate and establish processes that have impact cross-functionally, cross-divisionally and cross-geographically.
Ability to drive decision-making within a cross-functional and cross-cultural, global team structure.
Flexibility, tolerance and diplomacy to best manage change and differing opinions.
Ability to work in a virtual setting/across time-zones, i.e., making effective use of communication tools (WebEx, TelePresence, telephone and video conferencing, etc.).
Ability to inspire and motivate an interfacing and cross-geographical team.
Ability to work in a highly complex, multi-cultural environment.
Highly effective communications skills written and verbal.
Management of multiple tasks of varied complexity simultaneously.
Excellent organizational skills.
A solid business background as well as excellent commercial understanding is essential.
Effective negotiation and positive influencing abilities.
Fluent in English
Project Management Professional certification with PMI a plus
May travel to the US, EU and Japan offices and other meeting locations internationally.
Approximately 25% travel is required.
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