Major accountabilities:
- Contributes to the regulatory strategy of the clinical development program and can be assigned as co-author of the Clinical Development Plan. Contributes to the design, conduct, monitoring and reporting of clinical trials in close collaboration with the CRO. Provides clinical research expertise and medical expertise as needed.
- Oversees generation of clinical study protocols (Phi and Phlll/ adaptive trials) by CRO and warrants compliance with strategic study concept sheet/synopsis, clinical practices, state of the art development methodologies and regulations in order to produce scientifically sound and conclusive results.
- Involved in monitoring clinical trial conduct by CRO to assure timely completion of all trials. Can be assigned as chair/co-chair to lead joint clinical team if required. Supports CRO medical lead/ internal GPMD and Safety lead/ pharmacovigilance lead in signal detection. Oversees CRO input in safety and provides support to annual pharmacovigilance reports to (e.g. DSUR, PSUR, RMP) as needed.
- Collaborates with clinical Quality Assurance and warrants medical oversight over CRO for all clinical trials as needed. May function as author/reviewer for internal Clinical Development SOPs/ contribute to review and gap analyses of CRO's SOPs to ensure compliance with high quality standards. Supports GPMD and gives clinical and medical input into device development programs as needed.
- Supports GPMD, CRO and regulatory team in close collaboration in the preparation of regulatory documentation as needed. Deputizes for GPMD and represents the company as development expert in particular at pre-IND and pre-submission HA meetings as needed.
- Contributes to early development strategy within portfolio management. Supports Due Diligence medical director in due diligence activities as needed.
- Provides leadership in preparation of inspection readiness. Supports trial and project budget management together with GPMD and Clinical Operations as needed.
- Participates in onboarding training and provides guidance, assistance and mentoring, shares best practices and lesson learnt from previous studies as possible to support continuous improvement at BCD/GCD.
- Supports GPMD in collaboration with Medical Affairs to execute on publication plan as needed. Oversees the registry posting of study results as needed.
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum 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 careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
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.
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