- A passionate pharmaceutical physician (MD pharmacology) with a strong focus on strategy (currently pursuing a Strategic Management course from IIM-L)
- Over 15+ years of Med-Affairs experience including 11.5 years of experience in international markets (an above-country assignment).
- Multiple TA exposure Neuro-psychiatry, CV-diabetes-metabolism, Anti-infectives, Allergy, Respiratory, Nutrition, Immuno-Oncology and Dermatology.
- Participated in clinical development (ranging from first-in-human studies to phase IV studies) and strategic medical affairs studies
- Strong Scientific communication experience – poster, abstracts, manuscripts, oral presentations, and Video-shoots
- People leadership experience in an earlier role - leading a team of 9 medics/scientists in the earlier organization. Currently individual contributor leading matrix team.
- Responsible for change management - setting up AE reporting and medical information process, digital transformation, and social media activation
- Passionate about innovative medical affairs activities, digital activities, strategic clinical research, scientific communication, EE engagement, and patient activities
Manager
Global Medical Affairs Director
GSK Mumbai
05/2012
Current Title
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- Insight gathering, conceptualization, development, approval, initiation, monitoring, report writing, and publication of Strategic medical affairs studies to fill up key evidence gaps in the literature for neuroscience assets
- Clinical development and launch of neurosciences assets across India, China, Mexico, Brazil, Turkey, Taiwan & Korea.
- China Wellbutrin registration studies, Requip CR study
- US-FDA sNDAs and post-approval safety studies (PASS) for Ropinirole
- ISS studies aligned to the asset strategy
- VEO/HEOR & reimbursement activities
- Clinical science expert for early pipeline for clinical development secondments (n = 3, total duration = 1.5 years)
- Contributed “medicine vision” for each asset with an elaborate strategy for its clinical development plan as a clinical lead (n = 3)
- Contributed to the design, development, execution, publication, and communication of the key registration studies (n =8)
- Supported Medical writing activities for protocol, ICF, CRF, CTD dossiers (m2.5), CSRs, Clinical summaries, and publication
- Driven scientific communication like publications, posters, and speaking at conferences (see below)
- Phase I & II assets in tuberculosis – took part in medical monitoring, dose-escalation meetings, investigator meetings, and managing ethical & safety incidents.
- Phase III/IV studies (n = 4) for a neuroscience asset–driven medical monitoring, safety and regulatory discussions, strategic decisions about launch and publication
- Early pipeline neuroscience asset activities – participation in medicine vision, disease modeling and consortia engagement work
- Medical writing: Authored various publications, posters, conference abstracts, oral presentations, Video-on-demand lectures, clinical research protocols, safety and regulatory-related documents.
- Scientific Communications and publications [Also see below bibliography]
- Developed robust Sci-Comms plan for conference participation, medical booth, impactful medical affairs presentations, GSK-led medical education, scientific workshops, and emailers.
- Safety, labeling, and regulatory activities: This includes partnering with safety, regulatory, and labeling teams for various risk management plans, ensuring timely completion of regulatory reports, and conducting safety studies for GSK assets. These activities encompass:
- Safety assessment of signals – review of clinical databases, literature, and ACO creation
- Label updates: GDS, NCDS etc.
- Safety reports: Reviewing, supporting, and writing DSUR, PSUR & PBRER
- Risk mitigation plans (REMS, RMPs – EuRMP, GRMP etc.)
- Participating in a periodic safety review meeting (SRT). At times, contributions like a medical writing/review of the clinical section of SRT briefing documents were needed.
- RTQs: EMA queries and labeling updates – Hiccups for ropinirole, ICD for ropinirole, erythema multiformae for lamotrigine, cardiac channel abnormalities associated with lamotrigine etc.
- CTD modules – e.g., review and update of clinical over-view or post-approval document. It also consists of supporting the clinical trial data or replying to specific queries. (E.g., China).
- Medical Device - writing up EU-MDR compliant clinical evaluation reports (CERs) for medical devices (Imitrex)
- Paediatric investigation plans (retigabine & Sumatriptan).
- Social listening for safety assessment of an established product
- Provide strategic medical direction for PIRCs including medical assessment, and contribution to comms. Package & to decide DHCPL (in case of product recall).
- Epidemiology study for Ropinirole using GPRD database
- Audits and inspections – I have undergone two audits and one external ongoing regulatory inspection for a medical device
- Strong medical Affairs expertise – Neurosciences (11.5 years – above country role)
- Developed, approved, and executed strategic medical affairs business plans for antidepressants, anti-anxiety, bipolar, Parkinson's disease, and epilepsy assets.
- Led digital innovation projects, including content development for promotional emailers and non-promotional mass emailers. Won EMA gold award for E-reach
- Activated social media for disease awareness campaigns, receiving a silver award for the Carerhood project.
- Engaged in license expansion and business development activities, notably achieving label expansion for levetiracetam in Taiwan.
- Demonstrated excellence in product development and product launch across China, India, Brazil, Mexico, Korea, Taiwan, and the Gulf as well as a strong presence across Southeast Asian countries like Thailand, Indonesia, Malaysia, Philippines, and Vietnam.
- Previously ABPI medical signatory (now GSK-code signatory)
Medical Advisor (Associate Manager)
Merck Serono Mumbai, India
08/2010 - 05/2012.
- Strategic medical Affairs studies & ISSs (n = 7)
- Real-world studies and registries (n=2)
- Medical (people) leadership: 5 medics (MSLs and medical advisors) and 4 clin-ops team members (total 9) – built high performing medical team who led various above studies end-to-end.
- Medical Communication (Scientific & KOL engagement) Activities: Planning and successful execution of standalone meetings, satellite symposia, and conferences.
- Participated as a speaker in various local-country (India in earlier roles) and above-country conferences
- Generating and synthesizing medical insights: Advisory boards, Face-to-Face or digital meetings with HCPs-
- Train the trainer – An excellent coach and trainer for medical reps, PMs, trainers (SFE), team & medics.
- Oncology – I was responsible for an oncology portfolio for a brief period of time which covered lung cancer. I was responsible for medico-marketing,
Medical Advisor (Associate Manager)
Unichem Laboratories Mumbai, India
12/2008 - 08/2010.
- To drive medical support to generic pharma: Product training to field force, Medico-marketing activities, focus-group meetings, advisory board meetings, stand-alone meetings, Driving and developing campaigns, Product launches and BD activities and Conferences and standalone meetings
- Established adverse event (AE) reporting and medical information system
Clinical Research Physician/Medical Writer
Various organisations in Mumbai, India (Part-time roles)
08/2005 - 01/2008.
- Part-time role in various CROs working as a study physician for BA/BE studies
- Medical writer for oncology & immunology – palbociclib, Lenvatinib, Eltrombopag, Octreotide LAR, Letrozole, alkylating agents, and an SLE asset in the development
