Job Description

The Drugs for Neglected Diseases initiative (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\xe2\x80\x99s 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\xe2\x80\x99 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. Since our inception, DNDi has delivered 12 new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 11-14 new treatments by 2028 \xe2\x80\x93 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 250 employees of 33 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. DNDi South-Asia was established in 2004. An integral part of DNDi\xe2\x80\x99s global network, it mobilizes and supports regional research and science institutions to develop an end-to-end approach to neglected diseases R&D. DNDi aims to co-create sustainable solutions with Indian partners while sharing expertise with the Indian biotechnology industry and ensuring access for patients and public health. It supports the implementation of R&D projects on visceral leishmaniasis, filariasis, pediatric HIV, Dengue, antimicrobial resistance etc. The R&D organisation drive therapeutic innovation from the lab bench to the patient bedside. it develops DNDi\xe2\x80\x99s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients\xe2\x80\x99 access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi\xe2\x80\x99s 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 include 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 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 lead the R&D organisation for all other topics.

Purpose of the position

The Nonclinical Development Manager is responsible for the coordination, organization and conduct of nonclinical activities, projects and experts\xe2\x80\x99 meetings, review of protocols and reports in accordance with GLP and ICH and other adequate regulatory guidance and local regulations. The incumbent supports Project Teams regarding nonclinical development and ensures communication between nonclinical experts/consultants and Project Teams. This position will also work with pharmaceutical companies on collaborative development of drug candidates to deliver DNDi\xe2\x80\x99s drug safety and toxicology contributions to those programs across the Neglected Tropical Diseases (NTD), HIV/HCV and Antimicrobial resistance (AMR) disease initiatives and across all development stages from preclinical to post-marketing.

Specific job responsibilities

• Review and writing of nonclinical study protocols, reports and data generated by external partners (toxicology, safety pharmacology, ADME, DDI, PK modelling, bioanalytics).
• Quality check of data and documents before registration in databases or use for presentations. Ensures and performs registration of documents in internal databases.
• Performs comprehensive literature search on ad hoc basis.
• Prepares scientific data compilation on ad hoc basis and presents them.
• Provides support during procurement process and selection of vendors.
• Drafts nonclinical sections of regulatory documents (IB, briefing book, etc\xe2\x80\xa6).
• Has a secretary role and take minutes during projects\xe2\x80\x99 and experts\xe2\x80\x99 meetings.
• Management of nonclinical studies according to planned timelines and budgets and in interaction with partners and vendors, all the way from vendor selection to internal reviews.
• Support the Nonclinical Development Leader by providing support.
• Responsible for archiving of nonclinical material and data (SOP, coordination, compliance, etc...)
• Depending on Project Teams, acts as nonclinical representative, takes care of the nonclinical coordination and logistics or acts as deputy of the Nonclinical Development Leader on an ad hoc basis.

The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities in line with your grade. This job description may be subject to review.

Reporting line

• The Nonclinical Development Manager shall report to the Non-clinical Development Leader.
• The contributing manager will be Director, South Asia.

Interactions

• Works as part of the Translational Sciences team within the Integrated Clinical Development Sciences (ICDS) department.
• Works as a member of (multifunctional, internal and external) Project Teams.
• Works with industrial partners, CROs, and other drug development organizations.
• This role has a representational role through the promotion of programs and maintain productive relationships by projecting outside DNDi the image of a credible partner.

Job requirements

Skills and attributes

• Strong ability to use initiative, to prioritize, be multi-task, and to work well under pressure to meet deadlines.
• Clear and systematic thinking demonstrates good judgment and problem-solving competencies.
• Strong communication skills in multicultural, multi-lingual environments
• Strong ability to work effectively as part of a multicultural team.
• Well organized and structured
• Strong analytical skills
• Strong ability to provide high level support in project/program delivery.
• Strong ability to manage parts of development programs with budget management.
• Strategic thinking and leadership abilities
• Strong management, negotiation, and advocacy skills
• Has autonomy for taking actions and decisions.
• Strong ability to interact with external stakeholders.
• Lead and motivate a small team for optimum performance, supervising junior staff.

R&D technical skills

• Strong knowledge of Nonclinical Development (Toxicology, pharmacology, ADME, pharmacokinetics and pharmacodynamics modeling and simulation), especially for small molecules (NCEs) and ideally with some knowledge on biologics.
• Strong ability to propose, initiate, design, monitor, understand and report nonclinical studies.
• Good knowledge of Drug Discovery/Development.
• Good understanding of Clinical Research/Development requirements.
• Strong knowledge of regulatory (esp. GLP, ICH) requirements, notably to support First-in-Man studies.
• Strong technical writing skills (procedures, protocols, reports and regulatory documents).
• Very much at ease with Excel for analyzing and compiling scientific data.
• Experience within a nonclinical consulting company, CRO, or in a nonclinical management role within a pharmaceutical, biotech or PDP organization is desirable.
• Project management skills required. Certification is desirable.

Experience

• Minimum 6 years\' relevant experience in which at least 4 years at Senior Officer level
• Proven ability to work effectively in a team and multicultural environment and matrix structure.
• Experience of working in public and private sectors is highly desirable.

Education

• Advanced post-graduate degree or graduate degree with equivalent in experience to reach Master level (in biology, toxicology, life sciences, pharmacy, veterinary sciences or equivalent)

Other requirements

• Fluency in English
• Proficiency in local languages desirable
• Very good knowledge of Microsoft Suite

Other information

• Status: Full time two years (renewable)

To apply

• Deadline for application: accepting applications until 23 October 2023
• Only shortlisted candidates will be contacted
• Application submission for this position may close early if we have enough suitable applicants