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.

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.

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 – 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.

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 organization include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral Diseases. Medical Affairs (Pharmacovigilance, Clinical Quality and Assurance, Regulatory and Translational 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 organization for all other topics.

Purpose of the position

• The Acoziborole Industrial Liaison plays a critical role in the delivery of Chemistry, Manufacturing and Control (CMC) activities for the development and registration of acoziborole, a new treatment for Human African Trypanosomiasis (HAT).
• The role acts as the technical focal point for DNDi with its industrial partner and external Contract Development & Manufacturing Organisations (CDMOs).
• The incumbent provides guidance and supervises CMC activities on acoziborole, including the work of other team members, CDMOs, independent consultants and advisors.
• The role plays a major role in facilitating information flows and planning between DNDi and its collaborators.

Contribution

The Acoziborole Industrial Liaison realises the project objectives through application of technical expertise, integrated planning and operational management of external collaborators.

Scope of work (results)

The Acoziborole Industrial Liaison directly influences the quality of external technical activities and data, the compliance of CDMOs, the registration timelines and ultimately the approval of acoziborole.

Specific job responsibilities

DNDi activities:

• Develop CMC project plans, identify associated risks and establish mitigation strategies to support the advancement of acoziborole.
• Lead an internal CMC team including subject matter experts and consultants (e.g., API, formulation, analytical, process development, manufacturing, quality).
• Maintain CMC risk register, develop and/or implement mitigation plans.
• Resolve technical, quality or resource issues smoothly and escalate as needed.
• Review and approve technical reports and GMP documentation, according to qualifications, training and experience.
• Ensure compliance with DNDi Pharmaceutical Quality Policy and Pharmaceutical Development SOPs.
• Share proactively and on a regular basis development progress with the industrial partner team and provide consolidated recommendations to discuss and agree on the appropriate actions to achieve project goals with a particular focus on submission readiness,

Lead external CMC activities:

• Active oversight of CMC full development, manufacturing and regulatory activities at external CDMOs.
• Project management of CDMO activities to ensure timely delivery of activities.
• Management, curation and industrial partner review of all reports and documents required for CTD Module 3 and pre-approval inspections.

Industrial partner activities:

• Proactive and timely communication of issues or risks to the industrial partner that affect project strategy or submission timelines.

With the industrial partner CMC project leader:

• Meet on a regular (weekly) basis to share progress and agree priorities.
• Prepare agenda and content for joint CMC technical meetings.
• Prepare presentations for project governance bodies (Global Project Team, Joint Development Committee and Joint Steering Committee).
• Provide regular input to the industrial partner to build the project planning for CMC activities and attend the regular planning meetings organized by the GPM,
• Represent DNDi CMC and ensure a close interaction with the industrial partner CMC PL, who acts as the industrial partner point of contact.

Regulatory CMC activities:

• Active support of pre-approval inspection readiness activities at DNDi and CDMOs.
• Collaborate with the industrial partner for preparation of CTD Module 3.

The above list of responsibilities is not exhaustive. This job description may be subject to review.

Reporting line

• The role reports to the Pharmaceutical Development Director

Interactions

• May oversee the work of external consultants
• Works with the internal DNDi acoziborole project team, and has regular interactions with DNDi senior management
• Has frequent interactions with management and technical staff at CDMOs, as well as with key Industrial partner team members (acoziborole project leader, CMC project leader, industrial affairs, QA)

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 programme delivery and explore new areas of activities
• Very strong ability to interact with internal and external stakeholders

R&D technical skills

• Significant knowledge of CMC.
• Expertise in one or more relevant disciplines (e.g. chemical, formulation or analytical development, manufacturing, quality, regulatory CMC).
• Working knowledge of GMP practices and principles.
• Good knowledge of pharmaceutical regulations and guidelines (e.g., ICH, EMA).
• Excellent technical writing skills (procedures, protocols and reports).
• Training in project management and risk assessment desirable

Experience

• Over ten years in relevant mid- to senior-level roles in a pharma or CDMO environment.
• Experience in preparation of late stage regulatory documents (CTD/QOS/Module 3) and pre-approval inspections would be favourable.
• Proven ability to lead and work effectively in cross-functional project teams, and with external partners and stakeholders.
• Track record of successful delivery of CMC projects

Education

• Advanced post graduate degree or graduate degree in relevant subject (e.g., chemistry, chemical engineering, pharmacy)

Other requirements

• Fluency in English
• Proficiency in French desirable
• Excellent knowledge of Microsoft Suite, including planning software

Other information

• Status: Full time position, fixed-term (18 months)
• Work permit required for Germany, UK

To apply

• Please submit your application using the online form
• Deadline for application: Accepting applications until 3 February 2023.
• Only shortlisted candidates will be contacted.
• This position might close early if we have filled the position.