Director - Technical Project Leader (TPL)

Strategy

• Establishes technical development plans in line with priority classification of project, gated by clinical readouts as appropriate and with an enterprise view in consideration of overall portfolio priorities. Establishes high level summaries for presentation to management and stakeholders.
• Has advanced skill to identify, assess, manage, and communicate CMC risks / program risks. Due to seniority and experience, can handle more difficult risks, issues in more complex projects and handle multiple risks of DS/DP/Device even with junior CMC team members.
• Provides drug development expertise in addition to technical expertise. Follows standard process but at the same time thinks outside the box based on existing knowledge. Challenges the status quo, is curious and fosters creativity of team members and own creativity. Leverages existing knowledge and implements in the overall Global Project Team project strategy. Continues to follow and stands behind Global Project Team decisions. For complex late phase programs, supports Senior TPL for defined work packages. 

Interfaces

• Participates in boards and joins and/or can lead discussions in leadership teams. Is highly skilled in collaborative settings (i.e., external vs internal, CROs, DDs, in-/out-licensing settings). Approaches/analyses issues and collaborates with other line functions for optimal solutions.
• Takes into account multiple stakeholder perspectives and approaches to find optimal solutions and build commitment and consensus. Provides knowledge of industry, main competitors, customers and external environment – this includes healthcare industry and global industry, digital and technological advancements.
• Shares knowledge with CMC community, e.g., by lessons learned sessions. Uses knowledge and experience to challenge and influence CMC line functions and/or Global Project Team in background of the overall drug development strategy / industry insight.
• Actively contributes to Global Project Team beyond CMC line functions. Is able to navigate and manage the complexity of the disease area GPTs. Leads DDs for assets in development. Is able to cope with time pressure and senior management exposure.

People

• Learns to manage teams/stakeholders appropriately (utilizing their support). Brings forward sound proposals and shares lessons learned, without passing the blame.
• Anticipates setbacks and stays in control – takes criticism as intended for situations (not personally or toward particular individuals). Recovers quickly from problems and setbacks.
• Exhibits servant leadership and provides mentoring/coaching to junior TPLs, line functions and CMC team members to support their professional and personal growth. Leads by example and drives decisions.

Generic Activities

• Leads CMC teams (in a matrix set up). Leads CMC team and other meetings (agendas, minutes, action tracker, moderation).
• Acts as link and conveys CMC topics between Global Project Team, CMC line functions and CMC boards to support decision making. Sets the CMC team and sub-teams objectives in line with the GPT / PoC Team objectives. Communicates transparently.
• Is able to communicate and adjust the message based on the audience (i.e., level of technical detail, etc.). Has financial and resource oversight, budget accountability/oversight.
• Takes responsibility for successes and failures of own and team's work, holds self and team accountable for outcomes (shifts priorities to ensure success). Leads DDs for assets in development. Is able to cope with time pressure and senior management exposure.

Ideal Background

Education (minimum/desirable):

Advanced degree in life science, engineering or equivalent.

Languages:

Fluent in English

Experience/Professional requirement:

• Successfully demonstrated several years (minimum of 2-3 years) of directly related experience as functional project leader and relevant experience as Associate TPL or equivalent.
• Has strong scientific/technical knowledge & understands technical development tasks for Small Molecules or Biologics (minimum) and Mixed Modalities (ideal). Is able to establish/maintain DS/DP/Device supply plan (in alignment with the clinical supply project lead).
• Has fundamental knowledge of GMP and regulatory requirements. Has a solid cross-functional knowledge (PK/PD, tox, clinical, commercial) regarding drug development. Manages end to end technical drug development and knowledge. Completed basic project management training.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to E-Mail schreiben and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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