Medical Science Lead
4 weeks ago
About the company:
Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.
Key Responsibilities:
- Effectively lead the Clinical strategy from TPP till submission of the dossier to regulatory like (FDA, EMEA, DCGI,…)
- Prepares/Reviews CDP, IB, study protocols, ICF, briefing book for scientific advices, TLFs and CSRs
- Actively work towards approaches for faster completion of trials and having a patient centric approach.
- Actively attends standing meetings of boards, committees, etc.as and when required.
- Provides/Reviews medical inputs for study conduct as per applicable GCP, SOP and regulatory requirements.
- Provides inputs on study level data including GCP-issues report.
- Attends regular meetings with CRO and/or other vendors.
- Supports and oversees activities of study conduct e.g. site selection, interaction with investigators and other service providers.
- Accountable for accuracy of trial information in all trial Registries such as Clinical Trials Registry – India (CTRI), Clinicaltrials.gov etc.
- Contributes to medical aspects and take part in study initiation and investigator meetings.
- Provides/Reviews inputs in to protocol deviation decision.
- Oversees CRO and conducts study specific medical monitoring which includes review of daily lab alerts and SAEs to communicate with CRO regarding follow-up.
- Supports audits and inspections.
- Supports budget preparation of clinical trial (if required).
- Monitors safety of subjects participating in clinical trials.
- Supports pharmacovigilance department in preparing safety documents.
- Supports statistics team in the conduct of Data Safety Monitoring Board interim analysis meetings.
- Supports in DBL (provide inputs on Tables, Listings and Figures, participate in all DBL meetings).
- Prepares/Reviews Protocol Synopsis, Safety forms etc.
- Prepare/ Reviews study documents e.g. SAP, DMP, SMP, DSMB charter, MMP, Imaging charter.
- Provides inputs on final TLFs, works with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings.
- Leads Regulatory scientific meetings and MAA approvals (USFDA/EMA/PMDA/CDSCO and other regulatory authorities across different regions and countries) for clinical aspects.
- Interacts with CAB/Advisory committees/DSMB members.
- Supports in Handling of Regulatory, Marketing or any other molecule-related queries
- Medical monitoring which includes data reviews, EDC reviews.
- Prepares/Reviews IND / IMPD medical documents, annual updates, MAA/CTD and other regulatory
- Supports department activities like SOP preparation and review / external potential partner scientific discussions / consultant interaction.
- Supports in the dissemination of important scientific information through articles or presentations or training. 27.
- Performs other related duties as assigned.
- Line manage any assigned Medical science staff for their respective project, with coaching and guidance.(if any)
- Effective manage and provide and Medical rationale or justification on specific products or therapy areas.
Qualifications
- MBBS/MD/MS having around 12+ or more years of experience, higher degree such as PhD can also be considered.
- Knowledge of the biopharmaceutical industry, drugs and indications with an understanding of applicable clinical trial guidelines and regulations.
- High degree of professionalism, maturity, business understanding and passion.
- Strong written and verbal communication skills as well as strong interpersonal skills, with impeccable attention to detail
- Ability to collaborate effectively with internal and external stakeholders at all levels and influence decision-making.
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