Head Medical Sciences

Purpose To:
Provide medical guidance and inputs and ensure product as well as subject/patient safety interests for all Biologics products throughout the various stages - both during development and post development. Thus encompassing the complete clinical trial lifecycle such as therapeutic area expertise and strategic inputs towards study designs and subsequent data interpretation marketing approval planning and strategies medico regulatory interface and interactions medical operations/medical monitoring post marketing studies partner interactions across geographies market launches; manage vendors for all outsourcing activities; represent as a spokesperson for DRL Biologics for all medical and pharmacovigilance/safety aspects; provide guidance to all team members

Within:
Clinical council strategy and regulatory guidelines

With the objective of :
Actively assisting in the clinical development strategy and programs of DRL Biologics by providing medical and technical inputs that will enable ensuring compliance to regulations product and patient/subject safety successful peri and post approval engagements towards product approvals and launches

Roles and Responsibilities:

1. Planning Budgeting and Reviews - Medical Sciences Develop long term/ short term implementation plans for Medical Sciences functions in line with CD and program strategy (for both out-sourced and In-sourced clinical trials); cascade plans to team members allocate work and resources for implementation; evaluate performance of team and project plans in periodic functional reviews; provide status updates during the council review; monitor timely achievement of key deliverables in line with desired quality budget and timelines; resolve issues and escalations for smooth execution; Assist the CD head in developing new strategy (business driven/ science driven) for clinical trials by providing medical and technical inputs; Provide medical inputs to portfolio business development to aid decisions in product selection due-diligence for in-licencing of products.
 1. Achieve long term and short CD goals 2. Build capability to support Global Clinical trials 3 Achieve Business development objectives

2. Clinical Strategy Provide medical and clinical expertise in priority therapeutic/ disease areas (Oncology /Immunology/ Dermatology any other as per business requirements) and work with Clinical Sciences function to build and propagate scientific strategy.

Understand patient needs based on local medical practices. Vet the clinical strategy and protocol from the medical operations and Therapeutics point of view; Review the strategy to provide medical/ technical inputs on feasibility/ viability challenges (from medical practice practice perspective) and develop mitigation strategies; Plan data reviews and interpretation.

Engage and partner with a broad range of healthcare stakeholders- both internal and external and work towards enabling stakeholders on gaining deeper insights on concepts of Bio-similarity.

IN ORDER TO ensure robustness of overall Clinical Program Startegy appropriateness of clinical trial design for smooth execution of clinical trials and generation of adequate and good quality data for approval by Regulatory agencies.

3. Medical Operations Ensure and enable scientifically sound protocol development in line with medical practices and applicable regulatory as well as ethical considerations. Anchor and ensure proper set up and conduct of all trial related medical connect/ meetings such as IM DSMB NDAC/ SEC Therapeutic Area Advisory (TAA) and Ad board meetings.

Partner and co-own clinical trials strategies medical oversight/ medical monitoring and liaising with TAEs and clinical investigators for both out-sourced and in-sourced clinical trials.
Drive timely resolution/ remedial action to avoid impact on deliverables/ functioning of CROs.

Ensure complete medical oversight for  out-sourced and in-sourced clinical trials. Engage with CROs medical counterpart/ investigators to set expectations for ensuring proper medical decision protocol compliance issue resolution during the trials; participate in all the review meetings/ investigator meetings to provide advice from medical stand-point; medical review for the significant safety incidents reported during the trials and analyse cause; communicate with relevant stakeholders to build confidence; troubleshoot from a medical stand-point; act as DRL Biologics representative for any safety/ medical discussion during the trial (questions raised by investigators/ ethics committee); Report safety issues to the regulatory and answer queries generated from the regulatory during the trial.

IN ORDER TO ensure clinical trial execution in line with the regulatory ethical and safety guidelines.

4. Drug safety Work with PV team to ensure timely SAE and AE reporting in compliance with Regulatory guidelines individual case safety reports (ICSRs) INDs NDAs annual report summary statements and Periodic or Developmental Safety Update Reports (PSURs/DSURs) RMPs. Ensure continued risk benefit assessment of all Biologics products.

IN ORDER TO ensure safety of Biologics products throughout the life cycle of the product and maintain compliances per applicable regional /global standards.

5. Medical Writing  Build capability and execute MW activities for CD such as clinical study protocols ICFS clinical study reports investigators brochure abstracts manuscripts CTD modules for BLA/ MAA filings etc.

6. Biostatistics  Provide Medical inputs to Biostatistician for preparing the clinical study protocols data analysis and review of TFLs for clinical study reports.

7. Peri-approval activities and Medical Affairs  Lead external interactions with regulators prescribers KOLs partners etc. Participate in peri- approval Regulatory and partner engagements launch meetings respond to clinical regulatory queries during product approval and post approval.

Review and sign off on medical aspects prescribing information and training material for Biologics products.

Develop/ review manuscripts for publications; prepare presentations for scientific conferences

IN ORDER TO ensure adequate medical and scientific positioning of data for regulators and Medical fraternity for getting Regulatory approvals and Supporting commercialization.

8. Collaboration with other functions in CD across Biologics Domains and Other Biologics Units  Build relationship with other functional heads within CD; jointly define processes and protocols of collaborative working with functional heads for driving operational synergies; institutionalise and sustain communication platforms for information exchange issue resolution etc. across cross-functional teams; encourage team members to continuously interact with cross-functional teams to improve quality of results within stipulated timelines; leverage relationships with function heads to resolve cross-functional issues; Build and leverage cross domain connects with Product Development Strategy/Commercial Technical Operations/Manufacturing towards ensuring seamless cooperation and partnering towards Biologics and Overall Organisation goals. 
IN ORDER TO co-create processes and facilitate cohesive working with peers within CD across domains and across Business units as per business requirements and strategy.

Development Provide leadership and guidance to the diverse team. Develop functional and managerial capability in the team members. Define goals periodically review and provide continuous feedback. Collaborate with HR in manpower planning recruitment activities and skill building
IN ORDER TO maximize potential utilisation performance and continued development of team members

Qualifications :

MINIMUM REQUIREMENTS

Education & Experience: Post graduate medical doctor with more than 15 years of experience (including 3-5 years of Medical Sciences leadership experience) experience in different medical domains such as Medical Monitoring safety/ pharmacovigilence Medical Affairs etc. Thorough understanding and experience of working with Biosimilars both in developed and emerging markets

Business Understanding: Management of out-sourced study (CRO and service provider management) Management of in-sourced study Understanding of clinical research industry Understanding of Regulatory environment Commercial

Knowledge

- In depth understanding of Medical Science for Pharmaceutical Development
- Thorough knowledge of Good clinical practice guidelines and global regulatory guidelines
- Experience in managing Medical aspects of global clinical trials (US/ EU/ emerging markets)
- Drug safety
- Medical and scientific writing
- Medical affairs function
- Various tools and processes used in clinical trials.

Behavioural Skills

-Communicating & Influencing
-Commitment to Learning & Coaching
-Business Acumen & Decision Making
-Building & Leveraging Relationships
-Innovation & Problem Solving

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 1015-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 900000 patients having benefited from our products till date.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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  Work :

No

Employment Type :

Full-time