Dr. Divya S. Mishra
Medical Director, Hematology/Oncology, Medical Affairs-Therapeutic Expertise
Sector: Hospital & Health CareMember Since, August 23, 2023
Open To Work
An Oncologist, Researcher, Physician and lifelong learner with more than 17 years of experience in industry and academia in diverse, multicultural settings across multiple geographies. Has held leadership roles of increasing responsibility and complexity and possesses rich exposure to diverse areas encompassing Clinical trials across all phases, expertise of Medical Operations, Medical Advisory Services, Drug Safety, Clinical Development, Outcomes Research, Risk Management, Liaison & Coordination, Training and Mentoring. She has obtained significant clinical work experience in Oncology, Family Medicine, Nutritional and Lifestyle Medicine, Pain & Palliative Consultation along with experiential knowledge in implementing Healthcare Services and has a successful track record of ideating, implementing and delivering on high-performance metrics and being recognized for innovative thinking, excellent communication and presentation skills, team work, leadership of projects and therapeutic area expertise.
Master's degree (M.Med), Family Medicine (2013 - 2015) Christian Medical College Vellore
National fellowship in Palliative Medicine, Palliative Medicine 1 year fellowship program (2017 - 2018) Institute Of Palliative Medicine
Palliative care management in cancer patients and other NCDs. Clinical Work Experience in Palliative care centres of AIIMS and MNJ Cancer Hospital, Hyderabad. Conducted an audit focused on patient needs assessment and identified patients for the ‘Palliative care register’ for further assessments and Planning (per the GSF-PIG guidance). This provides baseline data as the first step in setting up palliative care services in the LBSNAA community and for creation of an NCD registry.
Post graduate Certificate course, Health Economics and Outcomes Research (2012 - 2013) University of Washington
Certificate in Health Economics and Outcomes Research Completed a Certification course in Health Economics and Outcomes Research with focus on : - Principles of Health Economics - Economic Evaluation in Health and Medicine - Practice of Health Technology Assessment (HTA) in a Global Environment -Capstone Project to describe the health care system and health technology assessment (HTA) processes of the United States with a team of 5 colleagues
PDCR (Professional Diploma in Clinical Research) ( - 2009) Catalyst Clinical Services, New Delhi
MD, Radiation Oncology (2001 - 2004) Motilal Nehru Medical College, Allahabad
3 year Degree program with Practical skills training in allied Kamala Nehru Hospital in Allahabad. Conducted MD Thesis on \' Radioprotection with Amifostine in Oral Cancer Patients\'
MBBS (1993 - 1998) Maharani Laxmi Bai Medical College, Jhansi
Activities and societies: As Secretary, Literary Society, I organized debates, extempores, creative writing competitions for two consecutive years. I was also a member of the women cricket team. Won awards in sports and debating competitoins.
Work & Experience
ICON plc (2020 - Present ) Medical Director, Hematology/Oncology, Medical Affairs-Therapeutic Expertise
Provide strategic and competitive insights into clinical trials to the pharma/biotech sponsors during pre-bid and bid defense meetings for their novel/biosimilar drug candidates. Lead discussions with clients related to details on project set-up and conduct, as well as potential scientific misconduct Support study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material as well as undertake risk-benefit analysis of a medical compound/diagnostic and/or device and develop Safety Development Plans, Pharmacovigilance Plans, and Risk Management Programs Support the feasibility group in developing feasibility plan and questionnaire and review feasibility results Provide continuous medical monitoring/oversight of ethical aspects and data integrity during study conduct, drive processes, define criteria, assess, and evaluate protocol deviations and recommend actions to be taken; project enrollment rate and suggest protocol changes/clarifications to ensure success. Medical review for regulatory submissions of Development Safety update reports in countries where ICON is legal representative and help to generate expert reports and support IAS/IAEs, NDAs/PLAs, and other regulatory submissions and participate in discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients as required. Provide therapeutic and protocol specific training to the project team or study sites and Investigators.
CMC Vellore (2016 - Present ) Visiting CoFaculty for the Post Graduate Programs in Family Medicine
Was Inducted as an alumni faculty by CMC Vellore to co-facilitate the conduct of the course for their PG diploma and Master’s Program in Family Medicine. The course ran across 12 centers in India enrolling an estimated 300 students per year. Delivered teaching through adult learning methods and diverse pedagogic tools such as lectures, tutorials, practical and workshops for practicing doctors across India.
LBSNAA, MUSSOORIE (National Training Academy for senior civil services officers) (2016 - 2019 ) Medical Consultant
Managed acute and chronic illnesses, sports injuries, dermatological problems, as well as management of addiction and psychiatric illnesses and chemotherapeutic management of cancers. Ensured administration of appropriate drugs to patients in line with safe medical practices Conducted patient management and counseling sessions for a community in a hill town. Implemented a system of online record keeping for the hospital thus creating an objective and accurate data repository of the ongoing status of patient’s heath, trajectory of the illness as well as a record of assessments. Led Hindi translation of WHO- Workbook of Carers for training Health volunteers in Northern India http://palliativecare.in/hindiversion- of-palliative-workbook-of-carers/?mode=list
Sukhda Hospital, New Delhi (2014 - 2016 ) Associate Consultant - Medicine
• Responsible for attending to OPD’s and treating patients of acute infections as well as chronic illnesses such as Diabetes, Hypertension, fevers, TB, asthma and other multi-organ pathologies. • Managed the indoor patients and emergencies at the hospital. This experience served as my transition into general medicine from a specialist Oncology focus, making my skill-set more relevant for majority of patients.
IQVIA (2014 - 2016 ) Associate Medical Director, Oncology, Asia
Responsible for leading medical and strategic advisory support for phase 1, 2 and 3 clinical trials for multinational Pharmaceutical/Biotech companies across Asia Pacific region in multiple solid tumor and hematology indications. Received recognition from the Business Development team for providing strategic inputs into study design of a phase 1 trial in Glioblastoma for a pharma major during an RFP, which led to changes in trial design and the study was awarded. This was selected for a ‘Best practice case study’ to be shared with a larger team at Quintiles. Conceptualized and conducted a region-wide Investigator survey by collaborating with regional medical, statistics and feasibility teams colleagues across countries in Asia on ‘The patterns of G-CSF usage during cytotoxic chemotherapy’ and subsequently accepted for presentation at ESMO Asia conference in Singapore in 2015. Received recognition and nomination to the Worldwide Development Rewards from Clinical project manager and Functional Manager for contribution to yet another challenging phase 1 study and meeting expectations of a demanding sponsor.
SFJ Pharmaceuticals, Inc. (2013 - 2014 ) Associate Medical Director, Asia/Consultant, Safety and Strategy, Global Clinical Development
Supervised and coordinated clinical development activities of clinical research organizations on behalf of SFJ for ongoing phase 3 clinical trials in India Served as the senior most contact for SFJ in India and contact person for investigators in India for medical questions related to ongoing trials Supported in safety reviews and medical data reviews and reconciliation for SFJ\'s ongoing oncology projects Provide strategic inputs for new projects and medical inputs into protocol related questions from regulatory bodies globally. Conduct safety reviews and medical data review and reconciliation process for Oncology trials globally. Protocol training, Investigator meetings, developed recruitment enhancement strategy for the ongoing global international phase 3 clinical trial and helped in implementation by clinical trial leads in India. Played an instrumental role in due diligence and strategic inputs for new projects and provided medical inputs into protocol related questions from regulatory bodies globally. Involved in safety reviews Review of Aggregate Safety Reports and Risk/benefit evaluations for drugs and medical data review and reconciliation process for Oncology trials Formulated recruitment enhancement strategy for the clinical trial sites in India.
Pfizer (2007 - 2013 ) TA Lead, Oncology and Outcomes Research, Medical Affairs and Research Division
Worked as an Oncology Medical Advisor and Therapy lead Oncology & Clinical development Advisor at country level and one of the 2 medical members for Area Commercial Teams (ACT), Oncology for Asia and EURIT regions. Responsible for the overall growth and performance of the entire inline Oncology and Hematology range of portfolio for Pfizer India - about 20 new and established drugs in Oncology. Awarded for “Best Medical Development Plan” in 2009. Received \recognition for the revival of the “Pfizer Excellence in Education & Research Initiative” in the Oncology therapeutic area in 2010. Received “Bronze Medal for Innovative Compassionate Use program” and making a difference to the access of medicines by patients during annual Pfizer awards in 2012. Recognized as a part of the ‘Select Talent Pool’ of Pfizer for three consecutive years. Oncology Teams remained one of the highest performing teams in Pfizer during the entire tenure of my medical leadership and support. Led the Outcomes research portfolio for Pfizer India and drove the local clinical development of in-line range of products across therapeutic areas such as Vaccines and Rheumatoid arthritis Presented medical rationale to National Drugs Apex Committee of Indian drug regulatory authority (DGCI) for successful approval of three clinical trials and three drugs for their marketing approval Created a network of practicing oncologists to generate relevant data for specific cancer types and steered medical advisory board meetings with Oncology experts at national and international levels, Initiated monthly journal club meetings to engage multi-country medical personnel in scientific discussions as APAC ACT team medical advisor. Authored two Oncology protocols and served as study lead for three Oncology phase 4 studies. Conceptualized and authored the first ever Educational Brochure series (OncoBytes) for the Oncology Sales Force to enhance their medical competencies.
Tata Memorial Hospital, Mumbai (2007 - 2007 ) Clinical Research Fellow, Radiation Oncology
Practiced Essentials of research work methods and evidence based medicine and Instrumental in structuring and streamlining the workflows associated with project involving a comparison of the latest treatment modalities for radiotherapy of head and neck tumours.
Cama & Albless Hospital (2006 - 2007 ) Registrar
Was Involved in treatment of female and pediatric tumours while working in close association with NGOs attached to the hospital also involved in various activities for patient benefit.
Nanavati Hospital & Medical Research Center, Mumbai (2005 - 2006 ) Research Associate, ICMR Project
Treated patients with a novel modality of hyperthermia in addition to radiation and chemotherapy, as the only hospital in the country to offer this facility Provided medical care and follow-up for outpatients and inpatients of Oncology Participated in seminars, conferences, cross-specialty lecture series, and tumor boards Collaborated as part of a team to create the layout for a new LINAC facility ensuring optimum space utilization, patients’ convenience and aesthetics Worked with NGOs and Patient support groups to organize cancer awareness talks for the patients and public.
Batra Hospital, New Delhi (2004 - 2005 ) Senior Resident,Radiotherapy
Was Involved in all aspects of treatment of patients of solid tumors including delivery of radiotherapy, chemotherapy & side effects management in this large multi-specialty private setup Led efforts to institutionalize academic excellence through seminars and workshops Worked in the free Outreach clinics of the hospital