Job Description

Non-Clinical Development Manager

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\'s poorest people. (https://dndi.org/).

Purpose of the position:

- The Nonclinical Development Manager is responsible for the coordination, organization and conduct of nonclinical activities, projects and experts\' 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\'s 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.

Tasks and 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.).

- Has a secretary role and take minutes during projects\' and experts\' 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

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