Translational Medicine Expert – Dermatology, Associate Director in London

Location: Westworks, London, UK

As a Translational Medicine Expert (TME) you will provide medical and scientific expertise and leadership to:

• Drive success of early global programs, develop and implement strategies to achieve Transition Decision Point (TDP).
• Drive success of late global programs by developing and implementing strategies, which lead to clinical pharmacology and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling.
• Support Translational Research in developing new indications, endpoints and biomarkers, using in vitro, in vivo, or in silico methods.
• Provide scientific expert assessments and support for in-licensing opportunities, including due diligences.

Key Responsibilities

• Early clinical projects (Phase I / II, “Discovery”): Develop, in collaboration with the dermatology TA, and work with teams to carry out strategies for the Translational Medicine component of drug development projects from Research to TDP in single or multiple indications, including post-indication expansion (PIE) projects.
• Late-stage clinical projects (post-TDP, “Profiling”): In collaboration with the dermatology TA Head: Act as a key leader in developing the Ph2-3 and post-approval profiling strategy for drug programs, representing TMDP on Global Project Team (GPT) along with other TM line functions. Provide support for dose selection, study design and other clinical pharmacology matters throughout the development cycle. Oversee conduct and interpretation of studies prioritized by the to support the pivotal trials, such as special populations, drug-drug interactions, mechanism of action assessments, Pediatric Investigational Plan, etc.
• Translational Research (TR; indication seeking, endpoint and biomarker development): In collaboration with the dermatology TA Head, BR Research scientists, other TM line functions (BMD, CS&I, PCS, PKS), develop strategies to identify initial or expansion (PIE) indications, and to obtain sufficient evidence to fund these ideas.
• Business Development and Licensing (BDL; in-licensing and out licensing compounds): Participate on BD&L teams as the TM representative.

General responsibilities

• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study.
• Provides medical and scientific leadership and expertise to all line functions on the study team.
• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups).
• Oversee publication strategy for TM studies; lead writing of scientific publications; present study results externally where appropriate.

Leadership

• Lead study-specific teams/clinical trial teams in partnership with other line functions.
• Lead BR-sub-team(s) on Global Project Teams for late-phase programs.
• Collaborate closely with other TM (especially CS&I) and non-TM (especially Project Management) line functions to ensure operational excellence, continued urgency, and close attention to timelines, costs, and subject burden in balance with high scientific standards and innovation.

Essential Requirements

• Doctoral degree, MD
• Board certified Dermatologist
• Preferably Ph.D. within dermatology/immunology
• At least 5 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
• Innovation: Seeks out new clinical discovery opportunities and approaches to reach TDP
• Recognized expert in field, driving success for individual studies and projects; respected by colleagues across R&D, Development, and externally
• Fluent oral and written English

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired

• Clinical Trials
• Cross-Functional Teams
• Data Analysis
• Data Monitoring
• Drug Development
• Drug Discovery
• Medical Research
• Medical Strategy
• People Management