Medical Science Lead

1 week ago

Bengaluru, Karnataka, India Biocon Biologics Full time

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, 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 GCPissues 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), 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 followup.
  • 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 moleculerelated 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. 2
  • 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 decisionmaking.

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