Medical Science Lead

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.