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01/09 Nivedita Tomar
Leadership Hiring at Biocon Biologics

Views:153 Applications:13 Rec. Actions:Recruiter Actions:1

Biocon - Lead - Clinical Development Program (15-20 yrs)

Bangalore Job Code: 972094

Clinical Development Program Lead


Exp : 15 - 20 Years


At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bring high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.

We are seeking a candidate for Medical Sciences within the Clinical Development and Medical affairs organization. Reporting to the Head, Medical Sciences, Senior Medical Lead will oversee the activities of Medical Lead and oversee the trial conduct by ensuring clinical / medical expertise and providing support in investigational, regulatory, budget preparation, audits/inspections and pharmacovigilance activities.

Responsibilities:

- Prepares/Reviews CDP, IB, study protocols, ICF, scientific advices, TLFs and CSRs.

- 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 into 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 CDPs, Protocol Synopsis/Protocol, IB, ICF, Safety forms etc.

- 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 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 submission medical documents.

- 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

- Performs other related duties as assigned

Qualifications:

- MBBS/MD/MS having around 10-15 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

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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