Global Biosimilars Clinical Development Associate Director

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott Established Pharmaceutical Division (EPD) is looking for aGlobal Biosimilars Clinical Development Associate Directorfor its global Pharma Division Headquarter based in Allschwil- Basel.Primary Job Function:Global Biosimilars Clinical Development Associate Director as a member of growth team within I&D and guides the strategies for new portfolio expansion aligned with EPD objectives.Global Biosimilars Clinical Development Associate Director establishes the Clinical Development Strategy and Clinical Program design for global biosimilar products, he/she is accountable for the delivery against agreed goals and objectives of approved clinical programs. Global Biosimilars Clinical Development Associate Director partners with cross function I&D and Commercial teams to develop and implement fit for purpose Clinical Development approaches and programs which are conducted in compliance with applicable laws, regulatory guidelines, quality standards and develops the strategy and design of the clinical programs for innovative products and LCM. Global Biosimilars Clinical Development Associate Director as a core member of Clinical development leadership Team sets strategic direction for Global and regional clinical development functions aligned with EPD Business objectives.Core Job Responsibilities:Clinical Development Strategic and Leadership ActivitiesServes as a core member of Clinical development leadership Team and helps in setting strategic direction for Global and regional clinical development functions aligned with EPD Business objectives.As a core member of Clinical leadership team, contributes in building and implementing right organizational framework for global clinical development team aligned with Business objectives.Responsible for management of quality systems of Clinical development to build efficiency aligned with EPD objectivesResponsible with other members for planning of departmental Budgets  and oversight of Budget.Responsible with other members for review of workload and planning of resources for department and strategies for efficiency aligned with EPD objectives.Core member of clinical development leadership team to review of talent for clinical development teams, identification of critical roles, development opportunities and succession planning.Responsible for guidance and mentoring of assigned pharmacokinetic scientist and safety physicians in the assigned therapy areaClinical Development Governance As a core member of the Clinical Development Leadership Team, sets strategic direction to the clinical development function and ensure execution in target Markets accordinglyResponsible for governance of all critical issues and non-conformances arising from clinical studies across various forums and if needed raise to I&D LT.Clinical Development Strategic and Leadership Activities for BiosimilarsLeads 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.Participates in due diligences for new licensing / co-development opportunities.Preparation of briefing books (clinical) and participation in scientific advice meeting along with regulatory, CRO and other functions.  Regulatory query resolution, follow up with health agency for country clinical strategy finalization along with other functions. Builds, maintains and makes available expert clinical integrated compound and Biosimilar knowledge.As a standing member of Growth Team contributes towards building the Biosimilar strategy and tactical plans, including future product portfolio development. Leads alignment with other Global Clinical Director (GCD) for respective TA for that proposed biosimilar/oncology molecules based on its indications and usages.Alignment with regional clinical/medical and regulatory team to finalize clinical development strategy.Stays abreast with medical/scientific knowledge, competitor landscape, current business conditions and clinical practices within the assigned Biosimilar to continuously improve innovation, speed, quality and productivity in Clinical design and approach to drive innovation outcomesBuilds and maintains network of external clinical experts including Subject Matter Experts and Key Opinion LeadersLeads 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.Defines operational execution strategies including timelines and cost, in close consultation with clinical development functions i.e. Clinical Science, Biometrics and Clinical Operations.Seeks endorsement of proposed clinical strategy and it’s business rationale with cross-functional stakeholders including regional medical/clinical functions when appropriate.Represents the clinical development function in various internal governance forums like I&D LT Approval meetings, Pre EIB, SLT meeting.Participates and supports L & A and BD teams in due diligences for new licensing / co-development opportunities.Clinical Program execution:Accountable for the 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 ensures new risk/issues are timely identified, assessed and escalated to stakeholders, including I&D Leadership team if required. Participates 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 committeesInterpretation of results, integration and discussion with in internal and external stakeholders (CRO, regulatory bodies, investigators). Follows up for timely delivery of results.Pharmacovigilance activities:Core member of the Product Safety Team for assigned productsReviews of Pharmacovigilance deliverables e.g. Risk Management Plans (RMP), Periodic Safety Update Reports (PSUR), Development Safety Update Report (DSUR) Addenda to Clinical overviews (ACO), etc.Regulatory Affairs activities: Responsible for the development and maintenance of clinical sections of regulatory submissionsLeads response to clinically relevant inquiries / deficiency letters from the Health AuthoritiesOversees Labeling Sub Team (LST) deliverables, provides clinical evaluation and proposes scientific strategies with regards to maintenance of CCDS, Master SmPC and any changes required.Preparation of briefing books (clinical) and participation in scientific advice meeting along with regulatory, CRO.     Minimum Education:Medical Doctor and/or Master or PhD degree in life sciencesMinimum Experience/Training Required:At least 10 years of experience in pharmaceutical industry with minimum of  3-5  years in respective Biosimilar and minimum 7 years Clinical Development experience.Expert knowledge of clinical trial methodology across all phases of development and  Branded Generic environment including Bioequivalence studies and immunogenicity studiesSignificant experience in emerging markets e.g. China, LATAM and Middle East.Demonstrated Experience with managing impactful relationship with Senior Leadership roles at local, regional and/or global levelExperienced in independently managing cross functional teams in a global matrix environment Ability to work in a fast-paced global complex cross-cultural environmentAbility to make effective decisions based on good science and data in compliance with regulatory requirements and risk assessmentsExcellent 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 areasExcellent English language skills, both spoken and writtenDo you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf.(If you want to upload several documents, don`t save in between uploading them to be able to do so. Once you save your uploads, you will not be able to add more documents)Job SummaryJob number: 31069002Date posted : 2023-10-13Profession: Research & DevelopmentEmployment type: Full time