Head Clinical Due Dilligence (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit GLOBAL COMMERCIAL OPERATIONS SZ
Standort Holzkirchen (near Munich)
Funktionsbereich BD&L & Strategic Planning
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 245639BR


Stellenbeschreibung

Lead the clinical due diligence (DD) team for our Sandoz Development Center (Small Molecules). Accountable for robust, balanced, and timely clinical DD evaluations of BD&L / M&A projects and clinical evaluations of in-house projects in close collaboration with other functions.

• Lead clinical DD across global Clinical Development, driving an integrated approach for the review, evaluation and recommendation for the clinical component of global (and regional or local as applicable) BD&L / M&A opportunities
• Ensure fair balance and accuracy of clinical DD evaluations, including a clear risk-assessment with mitigation options
• Accountable for the assessment of the appropriateness of clinical development plans suggested by partners or developing clinical development plans (including budget and timelines) for in-licensing deals under consideration
• Ensure that clinical expertise is provided to registration files and to responses to deficiencies letters, as applicable
• Supports relevant global teams in determining relevant strategies and focus – from a clinical DD perspective (i.e. Portfolio, BD teams)
• Ensure identification of post-deal closure clinical commitments (e.g. registry update, inspection readiness, support of co-development activities) and secures resources planning for these commitments in alignment with Head Clinical Development
• Clinical DD team: team lead, people development, budget and resource planning



BD&L & Strategic Planning


Mindestanforderungen

• MSc or PhD in Life Sciences
• 10+ years of experience in drug development with focus on clinical development spanning Phase I to IV
• Broad understanding of generic drug development, experience with bioequivalence studies
• Past contribution to clinical due diligence and clinical project / clinical program evaluations
• Expert knowledge of pharmacy, pharmacokinetics, bioanalysis, statistics and/or clinical trials
• In-depth knowledge of GCP and worldwide regulatory requirements regarding clinical development
• Solid medical/scientific writing skills and ability to analyze, discuss, interpret and present scientific data
• Strong communication and organizational skills
• Proven people management skills with demonstrated expertise in working on teams

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



Auf diese Stelle bewerben Zurück zur Übersicht