Assoc CMC Program Management Director

SUMMARY / JOB PURPOSE :

The Associate Project Management Director (CMC) drives the overall success of programs within Pharmaceutical Operations.

The role supports the CMC Pharmaceutical Operations and the overall department leadership team, key technical Leads and project teams.

This role helps plan, track and report activities within inter-disciplinary functions for various work streams. This individual helps create slide content for tactical and strategic meetings, provides timelines and tracks tasks at both internal and external meetings with the large and growing manufacturing and supply chain network.

This role works cross-functionally as needed to identify and follow-up on deliverables to ensure that team members are meeting milestones.

Essential Duties And Responsibilities :

Oversee and manage the effective coordination and facilitation of team meetings from a program management perspective with a focus on cross-functional integrated CMC activities at Exelixis CMO’s for molecules in both DC through IND stages, and IND through NDA stages for our biologics portfolio.

Ensure team meetings have prepared agendas, allot adequate time for presenters to prepare, and complete timely composition and issuance of meeting summaries.

Ensure the timely and adequate follow-up on action items, identification of project issues and resolutions. Act as point of escalation for project issues and resolutions.

Oversee the appropriate use of electronic information management tools to prepare and maintain project documents such as working product profiles, integrated project plans, project tracking and status reports.

Collaborate with Department leaders to establish meetings and charters for departmental governance and committee meetings.

Create and maintain program documentation including; agenda, minutes, action items, dashboards, goals and milestones, decision log, resource tracker, timeline, internal website for internal, and external activities.

Facilitate robust communication within pharmaceutical operations and cross-functional departments to ensure all functions are aware of changes in strategy and impacts to risks and resources.

Ensure team members accountable for on-time completion of tasks or milestones.

Perform critical path analysis and supports scenario planning for manufacturing and supply chain deliverables.

Actively identify areas that may lead the implementation of new processes and systems designed to improve the efficiency and effectiveness of the PSC function.

Supervisory Responsibilities :

None

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

BS / BA in a scientific and / or business discipline and a minimum of eleven years of experience; or,

MS / MBA in a scientific and / or business discipline and a minimum of nine years of experience; or,

PhD in a relevant drug or biological development discipline and a minimum of five years of experience; or,

Equivalent combination of education and experience.

Experience / The Ideal for Successful Entry into Job :

Depending on development experience, requires at least five years of project management experience.

Exceptional project management skills and experience managing a portfolio of multiple products, and prioritization of activities and resources.

Knowledge / Skills :

Excellent skills with Microsoft Word, Excel, PowerPoint, MS Project Professional or other project management tools to manage project scheduling and tracking.

Strong skills in communication, meeting management, and verbal, written, and presentation skills.

Ability to drive problem solving, decision making, and issue resolution.

Displays persistence and resilience to overcome project obstacles and drive to completion. Energetic, highly organized, detail-oriented, diplomatic and calm under pressure.

Able to deal with uncertainty in a constructive manner and generate options for moving forward.

Applies technical expertise in project management and contributes to the development of new concepts, techniques and standards.

Knowledgably about cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.

Working knowledge of drug development process and the Federal laws and regulations affecting the pharmaceutical industry.

JOB COMPLEXITY :

Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.

Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.

Uses professional concepts to contribute to development of company concepts and principles and to achieve objectives in creative and effective ways.

Working Conditions :

Notice to Recruiters / Staffing Agencies :

Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department.

Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.

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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.

The base pay range for this position is $160,000 - $226,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location.

The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.