Location: Latin America region, preferably in Brazil
The Drugs for Neglected Diseasesinitiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the world’s poorest people.
Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients’ needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.
13 new treatments for people with Sleeping Sickness, Visceral Leishmaniasis, Chagas disease, HIV, Hepatitis C, and Malaria that have saved millions of lives. We aim to deliver a total of 25 new treatments by 2028 – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID-19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low- and middle-income countries.
With more than 240 employees of 30+ nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply
The R&D organisation drive therapeutic innovation from the lab bench to the patient bedside. it develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICS clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDI functions, beyond R&D.
The R&D organisation includes three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Integrated Clinical Development Sciences (Drug Safety & Pharmacovigilance, Clinical Quality and Assurance and Translational Sciences), Regulatory Sciences, Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, Science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team leads the R&D organisation for all other topics
Purpose of the position
- The Senior Scientific and Medical Manager supports the provision of appropriate medical and scientific input & support for all activities related to R&D projects, in direct contact with the Head of Chagas Disease. These activities are medical training, feasibility of projects, medical review of data, medical information for the trial team, medical advisors/Clinical Project Leaders from Clinical Trial Units, investigators and KOLs under the guidance of the Head of Disease while following the standards and policies provided by the Medical Affairs Director.
Specific Job Responsibilities
The Senior Scientific and Medical Manager is accountable for:
- Providing appropriate medical input & support for all activities related to clinical studies such as research protocols, preclinical documents writing, medical training, feasibility, medical review of data, medical information for the trial team, to medical managers and advisors/clinical Project Leaders, investigators and Key Opinion Leaders.
- Collaborating with the trial statistician(s) to develop studies SAP.
- Providing the high-quality review and interpretation of trial outcomes for assigned studies and oversee the presentation thereof in clinical study reports, and related study documentation to varied team and audiences.
- Assisting in the ClinOps process to ensure compliance with local laws and regulations, contribute to drug safety reporting and evaluation processes and respond to requests from field staff, addressing objections and issues promptly
- Supporting the collection of and consolidate medical data, ensuring the highest ethical standards are met
- Reviewing study CSR, after its development by ClinOps responsible linked to the study, with particular focus on the interpretation of efficacy and safety; validate before it is shared with the Head of Disease
- Initiating clinical and scientific activities and projects, from the conceptualization, together with the Head of Chagas Disease, and merging R&D and Access activities
- Responsible for risk identification and assessment, mitigation planning, and in the context of clinical trials, support the implementation and monitoring of internal controls within the area of responsibilities.
- Ensuring medical insights are provided to cross functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others.
- Coordinating the review and approval of medical materials and locally developed promotional materials, in coordination with Chagas Access Senior Manager ; ensure medical materials provided from global or region for partner engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines.
- In close coordination with the Head of Chagas ensuring the proper project management of the product portfolio for the disease program by proposing and implementing a product management framework and tracking progress
Other general contribution to R&D activities
- Participation in strategic discussion of the Clinical Development Portfolio, including regulatory
- Contribute to the selection of CROs and work effectively with partner organizations to conduct clinical trials in accordance with the clinical development plans, GCP/GLP, and applicable regulatory requirements, which is under the responsibility of the CPM.
- Attend project team meetings and provide input as appropriate.
- Provide expertise and act as a reference for all medical operational activities related to the projects/studies he/she is assigned to.
- Support fundraising team, as applicable (e.g. coordinate work package/grant, donor report)
- Contribute and Review scientific publication, and participation in publication release and results presentation in international congress, as applicable
- Participation/presentation in DNDi or expert management meeting (e.g. RDLT, SAC)
- Participation in management partner relationship
- Additional /specific/projects responsibilities
- Contribute to response to treatment and progression biomarkers strategy design and set up, together with the Head of Chagas Disease.
- Is accountable of the implementation of the Monitoring and Evaluation framework for Chagas Disease program, merging R&D and Access activities
- Is accountable to redesign Chagas Disease Platform scientific content and directions, together with the Head of Chagas Disease.
Reporting line
- The Senior Scientific and Medical Managerreports to the Head of Chagas Programme.
- Additionally, Senior Scientific and Medical Manager will have the Cluster Director as second line manager.
Interactions
- Works very closely in partnership with the Head of Chagas Disease, works with broader Chagas Disease team, with the LATAM Regional office team and Medical Affairs and ClinOps department, and more broadly with the R&D teams
- This position promotes programs and maintains productive relationships by projecting the image of a credible partner and ensures commitment of partners, in Latin America and abroad.
- This role promotes programs and maintains productive relationships by projecting the image of a credible partner and ensures commitment of partners.
Job Requirements
Skills and Attributes
- Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Very clear and systematic thinking that demonstrates strong judgment and problem solving competencies
- Very strong communication skills in multicultural, multi-lingual environments
- Very strong ability to work effectively as part of a multicultural team
- Very well organized and structured
- Very strong analytical skills
- Very strong ability to lead project delivery
- Very strong ability to manage large size projects with budget management
- Strong strategic thinking and leadership abilities
- Very strong management, negotiation, and advocacy skills
- Very strong ability to exercise high degree of independence to support program delivery and explore new areas of activities
- Very strong ability to interact with internal and external stakeholders
- Lead and motivate a team for optimum performance, supervising junior staff
R& D Technical Skills
- Excellent knowledge of Chagas Disease/academia knowledge
- Excellent knowledge of Clinical Research/Development
- Strong knowledge of Drug Discovery/Development
- Excellent Technical writing skills (procedures, protocols and reports)
- Knowledge of Regulatory (GCP, GLP and GMP) will be highly valued
- Knowledge and experience on Implementation Research will be highly valued
- Knowledge and experience on Participatory Research will be highly valued
Experience
- Over 5 years in Senior role in Clinical Research and Clinical Trials or equivalent
- Proven ability to work effectively in a team environment and matrix structure
- Experience of working in public and private sector is highly desirable
Education
- A Medical Degree (MD) with specialization in infectious diseases (PhD in Infectious diseases or related) is required.
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level in clinical research or equivalent area
- Formal training or certification as required by the function
Other Requirements
- Fluency in English and Portuguese
- Proficiency in Spanish
- Very good knowledge of Microsoft Suite
Other information
- Status: Full time – Permanent role
How to apply
- Please submit your application using the online form
- Deadline for application: accepting applications until 20 July
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants
