Director Medical Due Diligence mfd
Director Medical Due Diligence mfd
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Job Description
Job Description Summary
Responsible Global Clinical Development (GCD) representative for due diligence (DD) activities. Supports the DD lead as Single Point of Contact (SPoC). Leads the GCD subteam of subject matter experts (SMEs) in and throughout all phases of DD including the Confirmatory Due Diligence (cDD).As primary GCD contact provides input into DD involving additional clinical development functions and interfaces to investigate identified key questions/risk as needed.
Job Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company Sandoz aims to increase its strategic focus operate with greater agility set clearer business objectives enhance shareholder returns and strengthen its culture for us the Sandoz associates. This is an exciting time in our history and by creating a new and ambitious path it will provide a unique opportunity for us all both professionally and personally.
Join us as a Founder of our new Sandoz!
Your Key Responsibilities:
Your responsibilities include but are not limited to:
- Provide input to all phases of DD by focused assessments and based on confidential data
- Identify key opportunities risks and gaps
- Identify and address key focus topics
- Drive Clinical Line Function assessment documenting reasons for GO / No GO decision to proceed to cDD mandate:
- Support preparation of management decisions
- Conduct Confirmatory Due Diligence (cDD) by leading team of SMEs from relevant GCD line functions according to project needs i.e. including specific clinical expertise for comprehensive and indepth assessment of available data/source data/safety data to ensure detection of risks trends and to identify potential issues and risks to patient safety
- Coordinate SME team review discussions and recommendation as well as SME team meetings
- Participate in onsite visit (if required)
- Drive team recommendation based on integrated view on GCD opportunity and prepares final LF approved assessment on behalf of GCD
- Lead the elaboration of comprehensive accurate and aligned clinical development plans and costs
- Drive evaluation of internal and external budget for potential opportunity covering all GCD line functions
- Presents scientific / technical DD findings to GCD management
- Responsible for GCD DD report
- Support Scientific Deal Review preparation
- Updates GCD LT about the progress of the ongoing DDs
What youll bring to the role:
Essential Requirements:
- MD or PhD ideally combined with business management training at least 5 years solid experience and background in biopharmaceutical clinical development
- Extensive drug development expertise and experience in clinical development spanning across several therapeutic areas including biosimilar development
- Strong interpersonal and leadership skills ability to integrate across functions and organizations to build collaborative relationships
- Ability to work in a global team and matrix structure organization
- Wellorganized excellent time management with respect to priorities and selfmanagement
- Excellent communication (written and verbal) coupled with excellent interpersonal skills
- Fluent English (oral and written)
Youll receive:
Sandoz has an employeefirst approach and thats why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200000 learning videos and 5000 courses.
In addition to the various learning opportunities we offer company benefits such as:
- 30 days of annual leave
- Holiday allowance
- Additional rewards for special occasions (e.g. service length awards marriage celebration etc.
- Company pension schemes and capital formation benefits
- Parental leave
- Other offerings such as bike leasing
Why Sandoz
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz a leader in this sector touched the lives of almost 500 million patients last year and while we are proud of this achievement we have an ambition to do more!
With investments in new development capabilities stateoftheart production sites new acquisitions and partnerships we have the opportunity to shape the future of Sandoz and help more patients gain access to lowcost highquality medicines sustainably.
Our momentum and entrepreneurial spirit is powered by an open collaborative culture driven by our talented and ambitious colleagues who in return for applying their skills experience an agile and collegiate environment with impactful flexiblehybrid careers where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Hiring decisions are only based on the qualification for the position regardless of gender ethnicity religion sexual orientation age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this please let us know in advance as a note on your CV.
Join our Sandoz Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities join the Sandoz Network here:
Skills Desired
Budget Management Clinical Research Clinical Trials Coaching CrossFunctional Teams Lifesciences People Management Risk Management Risk MonitoringRequired Experience:
Director
Employment Type
Full-Time
