Senior Clinical Program Manager – Regulatory Submissions

Mindlance, Inc.; South San Francisco (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A national recruiting company is seeking a skilled Project Manager to oversee project management of drug development processes. Responsibilities include leading cross-functional teams, managing regulatory submissions, and ensuring projects meet business needs. Ideal candidates will possess strong leadership, project management skills, and extensive experience in the pharmaceutical industry. This position requires a Bachelor's degree and relevant experience, with opportunities for career advancement within the organization.

Qualifications

• 7+ years of relevant experience for senior managers, 10+ for directors, 15+ for senior directors in the pharmaceutical industry.
• Strong performance on cross-functional teams.
• Familiarity with clinical trial execution and budget management.

Responsibilities

• Ensure alignment and execution of strategic objectives.
• Lead cross-functional submission teams.
• Manage budget forecasts and operational inputs for business development.

Skills

Project management

Leadership

Communication

Stakeholder management

Negotiation

Education

Bachelor's degree in a relevant discipline

Project Management Professional (PMP) certification

Tools

Microsoft Project

Planisware

Job description

Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at http://www.mindlance.com.

Job Description

Job Description:

• The Project Manager (PM) provides comprehensive project management for asset teams to ensure alignment and execution of research, development, medical, and commercial strategic and operational objectives. The PM serves as the program operational leader ensuring all cross functional deliverables are achieved on or ahead of schedule, within budget target, and with quality that meets or exceeds business needs. The PM’s responsibilities encompass asset strategic and scenario planning, program and submission execution, team effectiveness, resource management, risk management, and information and communication management. The PM needs to have comprehensive understanding of the governance process, strategic and tactical planning, and the foundational tools that support planning, communication, and continuous improvements in the area of operational delivery.

Additional Responsibilities - In some instances a PM may provide leadership in the following areas:

Alliance Programs (Co-development alliances)

• Leads the operations for alliance projects including contributing roles on alliance sub-committees and steering committees.

• Plays a leadership role in partnering with Finance to manage alliance budget forecasts and with Portfolio & Decision Analysis on asset valuation assessments.

• Provides operational inputs (e.g., timeline and budget) for assessments of new business development/partnerships.

Submissions:

• Provides comprehensive project management for regulatory submission activities for initial market authorizations in major regions, as well as supplemental applications of significant scope.

• Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals.

• Provides support to the team approximately 18 months in advance of a potential submission to map out submission contents and conduct scenario analyses of cost, schedule, and resource demands to identify the most efficient plan.

• Applies specialized knowledge of and expertise around endgame to contribute to the identification, evaluation, and optimization alternatives for the submission plan.

• Responsible for the development of the submission integrated MS project plans and resourcing plans for endgame activities.

• Leads the cross functional submission team.

• Partners with the Asset Team Leader to lead advisory committee preparations.

• Reports to PM Group Lead or Senior Director level PM

• Key unit team relationships include: PM Group Lead, Project Planner, Portfolio Director and other PMs.

• Key internal-to-GPD relationships include: Asset Team Leader, Partner Line members, and enabling functions to ensure high functioning matrix asset teams that can deliver our portfolio.

• Key external-to-GPD relationships include: Commercial Development, Research Project Leader and other Worldwide Research & Development, Medical Affairs, Global Health and Value, and other enabling functions (e.g., PDA, Finance) to ensure delivery of programs.

Qualifications

Minimum Training & Education experience required:

• Bachelor's degree in one of the disciplines related to drug development or business required. Advanced degree (PhD, PharmD, MBA) desirable.

• Mastery of project management skills and product development.

•Senior managers are preferred to have 7 or more years of relevant experience; Directors are preferred to have 10 or more years of relevant experience; Senior Directors are preferred to have 15 years or more of relevant experience within the pharmaceutical industry. Levels are determined by the qualifications of the individual and business needs.

• Professional PM Certification (Project Management Professional [PMP] or equivalent) desirable.

Prior Experience/Skills:

•Strong track record of performance on cross-functional teams and results through effective implementation of project management methodology, tools, and techniques.

• Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven performance in business performance and project delivery.

• Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.

• Experience with stakeholder management, governance management, and communicating key messages to senior-level stakeholders.

•Demonstrated ability to utilize project management tools and techniques(such as developing integrated project plans, critical path management, project change control, project risk management, and decision
analysis).

• Extensive hands-on experience using Microsoft Project or equivalent project planning system to create and manage project timelines (Planisware and Snapshot experience highly desirable).

•Familiarity with clinical trial execution, working with contract research organizations, budget management, and related areas highly desirable.

• Track record for delivery against challenging personal and team goals.

• Knowledge of medical and commercial issues that drive late stage development and life cycle management is desired.

• Proven ability to succeed in a fast-paced, challenging and complex matrix team environment.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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