Group Lead - Medical Monitoring & Safety

Job Description

Job summary

We are seeking a seasoned individual to provide crucial medical oversight for clinical trials, ensuring ICH GCP (International Conference on Harmonization Good Clinical Practices) and protocol compliance, prioritizing subject safety, and contributing to the success of biopharmaceutical advancements. The ideal candidate will play a pivotal role in maintaining high-quality trial data and supporting pharmacovigilance, medical affairs and other medical related activities as needed.

Roles & Responsibilities

• You will be responsible for ensuring ownership of medical content in protocols, SEC (Subject  Expert Committee) documents, CSR (Clinical Study Reports), and clinical modules, before and during clinical trials. You will review and provide medical inputs for study documents like CTO (Clinical Trial Outlines), CRF (Case Report Form), SAP (Statistical Analysis Plan), protocol deviation handling plans, lab manuals, and others.
• You will handle site visits and interactions, and queries from ethics committee and regulatory bodies. You will bring in medical value to operational aspects of the clinical study (e.g. reduce screen failure rates and drop-out rates, ensure subject is evaluable per protocol)
• You will be responsible for review of monthly listings (Efficacy, Safety, Lab investigation, Pharmacodynamics tracker), Adverse Event  (AE) line listings and coded listings.
• You will provide medical inputs to BDRM (Blinded Data Review Meeting), perform sample size re-estimation, review study data, and prepare executive summary for regulatory submissions.
• You will identify and connect with Therapeutic Area Experts regarding CTO and CSP  (Clinical Study Protocol) development, and lead medical calls for clinical studies to ensure scientific decision making.
• You will hold critical meetings with Data Safety Monitoring Board regarding Constitution, Charter, Meeting content and Communications
• You will meet with SEC for protocol approval post CTO filing, and meet with investigators, regulators and partners to ensure protocol, safety management, and medical monitoring as needed.
• You will be responsible for organizing internal and external protocol training, and therapeutic area training.
• You will prepare and review Standard Operating Procedures (e.g. protocols, risk based monitoring, medical review, etc.), offer medical inputs for CROs, audit, and study budget assessment. You will also initiate and develop Medical Science Liaison (MSL) role with sites for specific therapeutic areas.
• You will be responsible for preparation and review of Pharmacovigilance related documents such as : DSUR (Development Safety Update Report), Annual Study Update, ICSRs (Individual Case Safety Report), Case narratives and Medical Review Manual among others.
• You will be responsible for global partner and Regulatory interactions, medical support to all pre-launch and launch activities, medical review and approval of product promotional material and presentations as needed. You will also sponsor causality assessment Benefit Risk Assessment of marketed products, and organize product launch trainings across countries as needed.
• You will perform medical query handling, post marketing studies, and review of regulatory safety documents, along with review and monitoring of safety signal detection. You will also develop and review medico-scientific communications manuscript and abstract for publication.
• Your additional responsibilities will include supporting cross functional discussions for finalization of clinical trial outline, and sharing knowledge towards medical depth training on various topics.

Qualifications

Educational qualification : M.B.B.S. or M.D. in Pharmacology

Minimum work experience : 8+ years of relevant industry experience

Skills & attributes :

Technical Skills

Behavioural skills

Additional Information

About the Department

Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.

With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.

With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.

Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.

We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure

Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

Benefits Offered

At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at