Director, Clinical Data Management Team Leader: Early Phase CDM

South San Francisco
California, United States of America


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The Position

Scope

The CDM Team Leader directs a local or regional team of 20-50 employees with multiple technical competencies across a single or multiple Roche sites. The CDM Team Leader’s direct reports will be primarily Managers and Principal level individual contributors. The CDM Team Leader reports to a CDM Group Leader, supporting an early development, oncology, non-oncology, and/or PD Medical Affairs business unit.

Purpose

The CDM Team Leader provides organizational leadership and strategic direction to ensure delivery of timely quality study databases for a CDM Team.  A CDM Team will be assigned a specific set of studies and the team is collectively accountable to ensure timely and quality completion of all CDM milestones and deliverables associated with these studies on an end-to-end basis.  The intent is for the teams to be large enough to allow resource sharing to address priorities but small enough to foster agility and rapid communication. 

The CDM Team Leader ensures alignment between CDM priorities and partner objectives and requirements.  The CDM Team Leader makes decisions related to processes, resourcing, and prioritization that impact the quality and timeliness of data availability for Roche clinical trials. These decisions can have a direct impact on Product Development’s ability to reach internal goals and corporate goals.

Key Responsibilities

  • Provide leadership to team with diverse technical skill sets, and accountable for delivery of CDM deliverables at the study level.
  • Establish and manage key internal and external partnerships and stakeholders in support of the business.
  • Partner with all other CDM Team Leaders to ensure that study work practices within the team balance consistency with global practices and meet the specific needs of partners and programs.
  • Oversee balancing and assignment of work across the CDM Team and coordinate transfer and/or sharing of tasks as needed.
  • Accountable for the CDM Team budget and resources, ensuring design and implementation of resource models needed to adequately staff all projects.
  • Leads team in support of the execution of the CDM mission and strategic priorities.
  • Develop a strong leadership pipeline for the organization through talent management and succession planning.

Critical Competencies

Strategic Agility

  • Articulates wise, long-term objectives and strategies that support partner needs and align with broader CDM objectives and strategies.
  • Maintains focus on a long-term strategy while successfully adapting to changing environmental conditions, based on a close connection to partners and the broader CDM organization.
  • Provides focus and direction to successfully navigate complexity and uncertainty.

Decision Making

  • Pushes decision making to the lowest appropriate level and develops employees’ confidence in their ability to make those decisions. Empowers teams to make decisions and holds teams accountable for owning the consequences of those decisions.
  • Stands behind decisions that have been made.
  • Understands the broad context for decisions and reflects that context in how decisions are made.
  • Makes good decisions even in the face of ambiguous circumstances or contradictory requirements.

Technical and Business Expertise

  • Demonstrates an ongoing commitment to reduce complexity across the organization.
  • Builds alliances with internal and external partners that strengthen our reputation and create new value.
  • Has a firm grasp of external conditions affecting the organization.

Communication

  • Makes people feel that they are truly heard.
  • Clearly articulates even the most complex concepts.
  • Encourages direct and open discussions about important issues.
  • Can be depended on to tell the truth regardless of the circumstances.

Managing Change

  • Leads change by example.
  • Understands the impact of change and new activity on the wider organization.
  • Adapts to changing external pressures facing the organization.

Inspiring and Influencing

  • Connects with people in ways that generate enthusiasm and commitment.
  • Finds opportunities to build community celebrate and have fun.
  • Rallies support throughout the organization to get things done.

Teamwork and Collaboration

  • Seeks common ground in an effort to resolve conflicts.
  • Builds bridges across geographical, cultural, and functional boundaries to enhance collaboration.
  • Brings out the best in people.
  • Finds and attracts highly talented and productive people.

Achieving Results

  • Aligns organizational resources to accomplish key objectives.
  • Delivers superior results by trusting and empowering resilient, adaptable, high-impact teams.
  • Recognizes individuals and teams for progress and smart risks, as well as success.

Feedback and Coaching

  • Seeks candid feedback on his or her performance.
  • Actively invests time to get to know people and what they do.
  • Acts as a mentor, helping others to develop and advance in their careers.
  • Encourages appropriate risk-taking to develop individuals through challenging stretch assignments.
  • Exhibits, encourages, and rewards behaviors that demonstrate an ability to ask for help and a willingness to provide help when requested.

Innovation

  • Challenges the organization to be curious, question the status quo and adopt new approaches.
  • Fosters a culture that leverages diversity and unique perspectives.
  • Has vision; often brings up ideas about potentials and possibilities for the future.

Experience and Qualifications

  • College/University degree – Bachelor degree or higher or equivalent education in scientific, medical or relevant technical discipline.
  • Minimum 8-10 years experience (significant experience working at a senior level) in the pharmaceutical/biotech industry with an emphasis in clinical data management.
  • Demonstrated performance in a senior leadership role including management of managers.
  • Knowledge of global regulatory requirements and GCP.
  • Comprehensive understanding of the overall drug development process.
  • Comprehensive understanding of the conceptual basis for CDM conventions, standards, and processes.
  • Understanding of the multiple roles and processes encompassed in CDM, including study data management, EDC system configuration, non-eCRF data acquisition, database lock, interim data delivery, SDTM conversion, reporting/metrics, and medical data coding.
  • Experience with resource planning.
  • Fluent English (both written and spoken).

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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