Tanja Obradovic Email & Phone Number

Dresher, Pa, Us

Dresher, Pa, Us

• Leading development of clinical oncology strategies across tumor indications and drug modalities focusing on optimal medical aspects of protocols and programs.• Consulting Pharma companies performing evaluation of the clinical oncology pipeline development from early to late stage portfolio• US and global strategies in preparation of clinical portfolio for interaction with healthcare regulatory authorities, treatment guidance organizations, and reimbursement bodies.• Evaluation of clinical study and pipeline strengths to meet medical need in cancer care and placement within existing treatment standards for novel immunotherapies, cell and gene based therapeutics, ADCs, Bi-specifics, targeted agents and other drug modalities.• Providing oncology therapeutic expertise on clinical study design, tumor indication development portfolio, clinical utilization of biomarker-driven development, global implications for the filing and post-marketing life cycle management.• Oncology standards of care and competitive landscape evaluation globally in support of building study and pipeline strategic approach and implications on execution effectiveness.

Tokyo, Jp

• Scientific clinical strategy development supporting comprehensive programs of novel cell and non-cell therapies for hematological and solid tumors.• Clinical development of CAR-NK cell therapy, Ab and small molecule agents across multiple tumor indications including hematological malignancies (DLBCL, FL, CLL, other) as well as solid tumors (NSCLC, melanoma, breast, CRC, prostate, head & neck, and other solids) • Integration of US and Global medical treatment, competitive landscape and policy needs into clinical development • Incorporation of immunooncology combination strategies into clinical development plans/protocols and RWE assessments• Leadership of strategic exchanges with KOLs and societies

Rahway, New Jersey, Us

• Acting as Keytruda HQ Strategy Lead with responsibility for the development and execution of Health Systems Oncology (HSO) Medical Affairs strategies in US, input and alignment to the Oncology Global Medical Affairs Plan. • Development and execution of US Regional Medical Affairs plan in collaboration with multi stakeholder HQ and Field tumor teams.• Responsible for providing medical input into development, execution and interpretation of clinical protocols including investigator initiated, academic and consortia studies/collaborations. • Leading Scientific Value and Quality of Care Strategies in support of meeting external stakeholder (scientific/key decision making leaders, practitioners, payers, pathways, compendia, policy bodies) needs on indication specific and pan-tumor topics . • Leading Oncology Quality of Care measures improvement and development across prioritized tumor indications.• Direct medical writing activities associated with Medical Affairs.• Oversee external Insights received from medical community, clinical registries and healthcare landscape to evaluate safety issues and value data gaps associated with Keytruda treatments and collaboration with internal stakeholders on activities aimed at addressing identified needs by developing outcomes research studies addressing safety and efficacy RWE, Biomarker-driven sub analysis, and new clinical studies.• Medical Affairs representative on internal teams communicating with key organizations such as Centers for Medicare & Medicaid Services (CMS), American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), American Cancer Society (ACS), Oncology Biomarkers Consortium (OBC), College of American Pathologists (CAP), National Committee for Quality Assurance (NCQA), National Quality Forum (NQF), National Cancer Institute (NCI), Oncology Nursing Society (ONS), Society for Immunotherapy of Cancer (SITC) and other organizations focused on Oncology care.

Rahway, New Jersey, Us

Member of dossier and filing execution for Keytruda studies with focus on label creation worldwide including USA, EU, Asia (including Japan and China), Canada and many other countries including those in Latin America.Membership of large multidisciplinary team responsible for alignment of reimbursement authority responses with US and ex-US label considering clinical and commercial strategy.

Rahway, New Jersey, Us

• Development of protocols for clinical studies across translational, early and late pipeline and responsibility for initiation, monitoring and reporting of internal Oncology clinical trials as well as external Academic and Cooperative Group collaborations with National Cancer Network (NCI/CTEP), National Comprehensive Cancer Network (NCCN), SWOG, and EORTC. • Acting as Program lead creating drug profile presentations/technical reports/clinical development plans in support of gaining input and/or funding approval by higher management (at PDTs, EDTs, LDRCs) aiming for comprehensive presentation of critical advantages in light of disease physiology, unmet medical need, regulatory plans, market positioning and leadership on successful filings/approvals.• Authorship and review of program level execution strategies, project, budget and people management, oversight of CROs, authorship and review of INDs, NDAs, CSRs, IBs and other protocol and program documents.• Authorship of Biomarker Clinical Plans across indications. Responsible for internal support/reporting of translational trials, analytical and clinical validations including coordination of IVD development and clinical research. Biomarker pipeline presentations to Academic and Society External collaborators and formulation of responses to regulatory agency or IRBs covering internal or collaboration studies.

Exton, Pa, Us

Design and oversight as well as reporting of preclinical and clinical pharmacology studies (PK, ADME, drug-drug interactions, food effect, biomarker explorations.Study Director leading collaborations with KOLs aimed at establishing comprehensive profiles for drug pharmacology in support of advancing research pipeline or regulatory submission packages supporting major and minor companies located in USA, Europe, Japan.

Philadelphia, Pa, Us

Head of pharmacology laboratory focused on immune system effect on cancer, tumor drug delivery, and central/peripheral molecular/metabolic drug responses.

Work focused on serotonergic drugs’ effect on cancer, immunity and central nervous system.Lecturing several courses class size 50-100 students

Doctor Of Philosophy - Phd, Pharmacology And Toxicology

Bachelor Of Science - Bs, Molecular Biology And Physiology