About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of.

Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount on Abbott stock purchases, among others.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

We offer flexible work policies that allow a healthy balance between personal and professional life

We invest in the development of our employees through training andgrowth opportunities

We foster an environment where every voice is heard and valued

The Opportunity

This position works out of our São Paulo location in the Established Pharmaceuticals Division. We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

As a Global Clinical Development Manager- Biosimilar (Oncology) You have the chance to lead clinical evaluation of new development opportunities, designing innovative, insight driven (internal and external), scientifically sound, risk-based and compliant global clinical development programs based on the agreed target product profile, timeline aligned with EPD’s strategy and business environment.

What You’ll Do

Clinical Development Strategic Activities for Oncology

• Stays abreast with medical/scientific knowledge, competitor landscape, current business conditions and clinical oncology & Immunology practices to continuously improve innovation, speed, quality and productivity in clinical design and approach to drive innovation outcomes.
• Responsible for overseeing/tracking clinical trial activities along with partner(s), review of clinical study design, sample size, country scope, population etc. Work on risk minimization strategy for successful clinical study outcome. Identify acceleration opportunities.
• Build, maintain and make available expert clinical integrated compound and Oncology knowledge. Involve in post marketing study design along with global medical team and clinical operation team.
• Contributes towards building the oncology strategy, brand plan and tactical plans, including future product portfolio development. Seeks endorsement of proposed clinical strategy and its business rationale with cross-functional stakeholders including regional clinical/regulatory/medical functions when appropriate.
• Participate in due diligences for new licensing / co-development opportunities for Oncology, Immunology/Biosimilar molecules.
• Preparation of briefing books (clinical) and participate in scientific advice meeting along with regulatory, CRO, Partner and other functions. Regulatory query resolution, follow up with health agency for country clinical strategy finalization along with other functions.
• Lead alignment with other functions for respective TA for the proposed biosimilar/oncology molecules based on its indications and usages. Alignment with regional clinical/medical and regulatory team to finalize clinical development strategy.
• Builds and maintains network of external clinical experts including Subject Matter Experts and Key Opinion Leaders. Evaluates, and reviews clinical literature, generates potential new differentiated ideas (incl. digital) to enhance and maximize potential benefit for disease management and patient care.
• Establishes and maintains strong relationship with clinical counterparts from external dossier providers.
• Lead final results analysis, interpretation, integration and discussion with internal (project teams, senior management, governance forums) and external stakeholders (CRO, regulatory bodies, investigators), including authoring of scientific publications.
• Collaborate with partner, global & regional clinical/medical team on publication proposals for oncology/biosimilars therapeutic area.
• Co-lead with marketing team the development of promotional materials, identifies suitable mid-and long-term differentiating opportunities, Brand Plan and ensuring scientific validity of the contents.
• Defines operational execution strategies including timelines and cost, in close consultation with clinical development functions i.e. Clinical Science, Biometrics and Clinical Operations.
• Represents the clinical development function in various internal governance forums like CDLT, Approval meetings, Pre EIB, SLT meeting etc.

Clinical Program execution:

• Takes ownership for clinical section of the module and ensure dossier completeness and coordinate with regulatory, medical, PV and other function to fulfill the country specific dossier requirements.
• Accountable for the clinical study conduct including design and operational delivery of the approved clinical programs according to the agreed budget and timeline and in compliance with applicable laws, regulations, ICH-GCP guidelines, and Abbott policies, in close collaboration with responsible assigned Clinical Study Team(s).
• Takes ownership for clinical study medical/safety aspects and assures continuous risk- benefit assessments for patients and healthy volunteers participating in Abbott sponsored clinical studies.
• Proactively identifies and monitors risks (compliance, business, patient safety, medical) throughout the clinical program life cycle and ensures mitigation strategies are in place and executed on.
• As a core member of the Clinical Operations Governance Board ensure new risk/issues are timely identified, assessed and escalated to stakeholders, including I&D Leadership team if required.
• Participate in the cross-functional Scientific Review Forum responsible for the review and approval of clinical trial related deliverables, including (but not limited to) clinical study protocols, safety review plans, clinical study reports, investigator brochure, clinical sections of regulatory submissions, response to inquiries from regulatory agencies and ethics committees.
• Interpretation of results, integration and discussion with in internal and external stakeholders (CRO, regulatory bodies, investigators). Follow up for timely delivery of results.
• Provides sound and up-to-dated clinical information, disease knowledge and clinical training to stakeholders such as e.g. I&D departments, Public Affairs, Marketing/Commercial departments, affiliate (clinical) teams.

Pharmacovigilance activities:

• Act a member of the Product Safety Team for assigned products.
• Review and update of Pharmacovigilance deliverables e.g. Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), Development Safety Update Report (DSUR) Addenda to Clinical overviews (ACO), update of CCDS etc

Regulatory Affairs activities:

• Responsible for the development and maintenance of clinical sections of regulatory submissions specially clinical modules (Dossier)
• Dossier gap analysis and provide mitigation strategies for ongoing products. Ensure all clinical activities comply with local and international regulations.
• Lead response to clinically relevant inquiries / deficiency letters from the Health Authorities
• Oversee Labeling Sub Team (LST) deliverables, provide clinical evaluation and propose scientific strategies with regards to maintenance of CCDS, Master SmPC and any changes required.
• Preparation of briefing books (clinical) and participate in scientific advice meeting along with regulatory, CRO, Partner

Required Qualifications

Degree in life sciences or Medical Doctor

At least 05 years of experience in pharmaceutical industry with minimum of 1-2 years in respective Biosimilar- Oncology and minimum 3 years Clinical Development experience.

Expert knowledge of clinical trial methodology across all phases of development, Biosimilar and Branded Generic environment including Phase 1, Phase 2, Phase 3, Phase 4 studies and immunogenicity studies.

Complete understanding of clinical dossier and country specific Regulatory requirements.

Significant experience in emerging markets e.g. APAC, LATAM, INDIA and Middle East.

Experienced in independently managing cross functional teams in a global matrix environment

Ability to make effective decisions based on good science and data in compliance with regulatory requirements and risk assessments.

Excellent clinical reasoning skills, with the ability to independently assess and conclude on published and in-house data related to pharmaceutical products and EPD’s therapeutic areas

Excellent English, Spanish & Portuguese language skills, both spoken and written

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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