Project Director, Drug Development
AbbVie - Lake County, IL

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130000002Z

Description

AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.

PRIMARY JOB FUNCTION:
The primary function of this position is to nurture, guide and direct the management of the research, development and registration of commercially viable New Drug Products {NDPs). This is accomplished through leadership of the cross functional Global Project Team (GPT). In the post-marketing setting, responsible for developing and executing product life-cycle strategy and assuring full scientific support of commercialization activities.

Participating with the discovery team in the selection of compounds in the pharmaceutical class as well as follow-on compounds after the first product candidate has been identified. Pre-clinical development of NDPs, including bulk drug synthesis and appropriate dosage forms for worldwide studies/marketing. Clinical development of NDPs throughout Phases I, II and III, and post market launch.

The planning for, and preparation and filing of, worldwide registration packages (e.g., NDA, BLA). In addition, wherever third parties are involved, the Project Director has the responsibility for developing and insuring compliance with maintaining the terms of associated agreements/contracts.

Responsibility for clear definition of" "Go/No- Go" decision points throughout the research and development of NDPs and making those decisions with the concurrence of the next level of management.

May Lead multiple GPTs

and act as project decision maker responsible for coordinating the successful development/registration of a new product and management of the life cycle of a marketed product within defined scope and budget

NDP Development - With PM, develops,organizes and leads the team(s) with concurrence of functional management to allow the development of each NDP to proceed expeditiously and smoothly toward registration and market launch in compliance with worldwide governmental regulations.

Leads the execution of the development plans of the NDPs. Project or Group Decision Maker. Sets overall and specific scientific strategic direction for the project or group consistent with business goals established in conjunction with the appropriate Therapeutic Area Executive Committee (TEC. Establishes project or group goals in conjunction with team members and all inter-project priorities. Directs development of project plans/schedules in conjunction with functional or area managers.

Develops all "Go/No-Go" decision points with the concurrence of team members. Makes the appropriate decisions at the designated times. Directs and motivates the team to meet project goals.

Develops and coaches NDP Project Staff and team in the management of the development and registration of NDPs and successful scientific support of commercial teams in the post-approval setting.

Maintains an up-to-date analysis of competitor's product candidates or products.

Participates as a member of TA Management staff and with PM, evaluates performance of team members and provides feedback to functional area heads on the performance of team members.

Reports to DVP or Executive Project Director for TA Clinical Development. Responsible for direction of medical and scientific staff in the TA. With PM, responsible for developing and organizing the GPTs.

The Project Director must be able to develop creative, effective solutions to inter- and intra-project priority conflicts, resource constraints and other problems which may impact project or group goals and deliverables.

High goal-orientation with the ability to see solutions rather than problems as projects encounter the inevitable ups and downs associated with new drug development or product support. The GPH must be a self- starter and have a strong desire to see projects achieve commercial success.

The Project Director by definition must perform at times in previously uncharted territory with few, if any, established guidelines or procedures. At other times, exceedingly complex governmental rules and regulations must be followed. For problems surrounded by complex rules and regulations, the GPH must be able to direct compliance knowledgeably and expeditiously. Additionally, this person must be able to interact successfully with senior management and act as the project/group champion and spokesperson.

This person must provide the leadership for NDP development, establishing the high standards required to obtain registration approvals in the shortest possible time. The Project Director will regularly be dealing with a wide variety of complex scientific and regulatory issues requiring technical expertise as well as skills in marketing, manufacturing, etc.

Track progress, in conjunction with GPT Project Manager, of execution of development or medical affairs program in terms of deliverables, timelines, and budget.

Establish and maintain effective and timely multi-directional communication within the GPT, internal governance committees, and functional area management.

Actively coach and provide and solicit feedback within the GPT to build a cohesive and motivated team to drive superior execution and high quality deliverables.

Continuously validate the viability of the project from a scientific and commercial perspective.

Determine, in collaboration with the Therapeutic Area TEC, the global development strategy for new or marketed products and contributes to the Therapeutic Area Long Range Plan and Portfolio Planning.

Drive the design and aggressive execution of a high quality development or medical affairs program supporting the therapeutic area strategy that effectively and efficiently meets ethical, scientific, regulatory, commercial, and quality requirements.

The Project Director will be accountable for the successful and timely completion of all project/program/group goals, milestones and tasks under his/her direct and matrix control.

Scope - This position has full responsibility to supervise the progress activities of the NDP team members in the accomplishment of all

program

goals and activities. Typically the team will consist of l0-30+ people either directly or through matrxied teams.

Qualifications

SKILLS/EXPERIENCE REQUIREMENTS

Minimum of 5 years of clinical trial or medical affairs experience in the

pharmaceutical industry or academia or equivalent. 7+ years of

experience is preferred. Proven leadership skills in a cross-functional

global team environment. Ability to interact externally and internally to

support global business strategy. Ability to run a complex clinical program

or medical affairs team(s) independently. Extensive knowledge of clinical

trial methodology, regulatory requirements governing clinical trials and

experience in development strategy and the design of protocols. This

knowledge set is typically associated with a minimum of 7 years of clinical

development or medical affairs experience in a pharmaceutical

company/CRO/Bio Technology company plus expert knowledge in a

relevant therapeutic specialty. Must have an understanding of

Pharmacovigilance practices for Clinical Development programs. Ability

to interact externally and internally to support global business strategies.

  • Must possess excellent oral and written English communication skills. Ex-
Us: At least one further major international language is preferred. Must

have an in-depth understanding of the Clinical Development process for

Phase I-IV or extensive knowledge of medical affairs including compliance

and regulatory requirements.

EDUCATION REQUIREMENTS

  • US: Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent
of M.D. meet requirements) with relevant therapeutic specialty in an

academic or hospital environment. Completion of residency and/or

fellowship is preferred.

  • Ex US: National licence to practice medicine with relevant therapeutic specialty in
an academic or hospital environment. Academic qualification (Dr med or

equal) is strongly preferred. Completion of residency and/or fellowship is

preferred. Advanced academic qualification is warranted.

Significant Work Activities and Conditions

Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)

Job Classification

:

Experienced

Job

:

CLINICAL RESEARCH

Primary Location

:

USA-Illinois-Lake County

Organization

:

GPRD-Pharma R&D

Schedule

:

Full-time

Shift

:

Day

Travel

:

Yes, 25 % of the Time

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