Director, Technical Project Lead

Job Description Summary

Position is on-site in Cambridge, MA
#LI-Onsite
About the role:
The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned projects covering small molecules and complex new entities within Technical Research & Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); maximize the support to local programs and partners; lead CMC teams with strong strategic focus, quality & environmental awareness, management capabilities, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes.

 

Job Description

Your responsibilities include, but are not limited to:

Lead the establishment of a scientifically & regulatory sound and business driven CMC project strategy including risk assessments and contingency planning, in line with overall global development project strategy and together with assigned CMC team.

Ensure alignment with departments and functions inside and outside of TRD as well as 3rd parties as appropriate. Drive endorsement of CMC project strategy by respective Novartis boards.
Proactively communicate overall project strategy, key risks, issues and any other critical topics in a timely manner to the appropriate management level, customer and stakeholders.
Ensure that issues are resolved in a timely fashion and not unnecessarily escalated.
Understand and proactively manage the cross-functional aspects of assigned project(s) among departments within and outside TRD (e.g. Regulatory, Safety, Clinical, Production, Research)
Lead the CMC subteam(s) in a complex international matrix organization in line with the culture, values and behaviors of Novartis
Build strong team spirit and promote knowledge exchange within and between teams. Align project objectives and priorities with team(s) members.
Support in- and out licensing of projects by shaping global technical development strategy for post-due diligence projects under negotiation.

Role Requirements:

• Education: Ph.D. or equivalent in chemistry, biochemistry, biotechnology, biology, pharmacy or related science.
• Language: Excellent English required (oral & written)
• Minimum of 8 years of experience within the pharmaceutical industry, preferably in the field of technical development; minimum of 5 years of experience in a leadership position
• Demonstrated minimum of 3-5 years project management excellence in technical development department (e.g. several years of experience as CMC project leader or senior line function position) or equivalent experience
• Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects (incl. budget control), in Technical R&D or equivalent experience
• Proven ability to work proactively and think strategically, including assessment of business impact of technical decisions
• Excellent verbal and written communication skills with success in building trustful relationships and influencing others in cross-functional areas including stakeholder management
• Excellent knowledge of the Pharma Drug Discovery & Development process

Desired Requirements:

• Experience in technical development of NCE compounds in the early clinical phases will be preferred

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally p