Head of Product Development, HIV/HCV Initiative

Geneva, Switzerland
[Closing date: November 26, 2017]
                                                                 

 

Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership, a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.

Since its inception, DNDi has developed seven new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

The HIV/HCV team aims to develop two solid first-line “4-in-1” fixed-dose combinations using the World Health Organization (WHO) recommended treatment regimen for HIV positive infants and young children. At the same time, DNDi and its partners in South Africa are also addressing the negative drug-drug interactions between WHO-recommended HIV treatments and the TB drug rifampicin through a process known as “super-boosting.” To address HEP C patients’ needs, the team’s objective is to develop an affordable public health tool using direct-acting antivirals (DAAs).

 

Purpose of the position

The Head of Product Development is responsible for planning and ensuring the proper execution of the development plan of the HIV/HCV pipeline of drugs being tested with the objective of being registered and made accessible to patients in relevant geographic locations. S/he ensures the coordination of product development activities in accordance with the clinical development, regulatory and access strategies. In particular, the Head of Product Development is responsible for effecting efficient and optimized project management of these workstreams, developing with the relevant team members, external experts and potential marketing authorization holders the strategy for registration of the drug candidates, effecting the preparation and submission of complete registration dossiers and fulfillment of post-submission requirements, and interacting with regulatory authorities and marketing authorization applicants/holders during the preparation, submission, review and post-registration process.

 

Specific job responsibilities

Strategic management

  • Contributes to the HIV/HCV disease strategy development
  • Ensures coordination of the Action plan process
  • Contributes to SAC documents
  • Manages the budget for product development
  • Ensures the coordination of the activities related to the development and registration of the drug candidates and products in the HIV/HCV portfolio using efficient and optimized project management
  • Contributes to all team meetings and leader’s meetings for HIV/HCV

Product portfolio strategies

  • Is accountable for ensuring the proper project management of the product portfolio for the HIV/HCV initiative by proposing and implementing a product management framework and tracking progress, supported by a Senior Manager in Planning and Finance. Initial focus will be on HCV
  • Optimizes development timelines as well as financial and human resources required to meet registration and access objectives
  • Coordinates the product development strategies of the HIV/HCV team for the successful registration, launch, and uptake of the products by end-users through feasibility/risk analyses involving or led by relevant colleagues
  • Makes recommendations on product cost and market positioning
  • Initiates new product(s) ideas through new product proposals
  • Coordinates and effects the creation, review, and validation of all components of registration files
  • Works closely with R&D and Business Development colleagues to in/out-license intellectual property

Product partnership / stakeholders management

  • Works with BD, procurement, and technical departments, contributes to due diligence and assessment of opportunities
  • In collaboration with Pharmaceutical Development colleagues, interacts with the production partners to ensure product availability and stable quality for clinical trials
  • Interacts with a full range of stakeholders on product development, product supply, and product quality

Regulatory and product registration oversight

  • Oversees the implementation of the activities necessary for the definition of the regulatory strategies for the HIV/HCV products, in close collaboration with the Head of Regulatory Affairs
  • Ensures consistency of all product development activities with the defined regulatory strategy

Other

  • Participates in fund raising, including contribution to grant applications
  • Provides other project support as needed

Reporting line

  • S/he reports to the Director HIV/HCV
  • Supervises the senior planning and finance manager

Interactions

  • Close collaboration with the Clinical Development Head for HIV/HCV, other members of the HIV/HCV team, the Head of Pharmaceutical Development, the Head of Translation, the Head of Discovery, and the R&D Portfolio Planning Leader

 

Job requirements

Skills and attributes

  • High 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
  • Excellent communication skills in multicultural, multi-lingual environments
  • Knowledge of managing global multicultural teams
  • Highly organized and structured
  • High analytical skills
  • High ability to lead large strategic projects, large size projects with budget management
  • Very strong strategic thinking and leadership abilities
  • Excellent management, negotiation, and advocacy skills
  • High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
  • High ability to interact with internal and external stakeholders, in particular, drug regulatory authorities
  • High ability to lead and motivate a team for optimum performance

R&D technical skills

  • Excellent knowledge of drug development project management
  • Excellent knowledge of drug discovery/development
  • Excellent knowledge of clinical research/development
  • Excellent knowledge of drug regulation and registration requirements (GCP, GLP and GMP)
  • Excellent knowledge of disease/academia knowledge
  • Excellent technical writing skills (dossiers, procedures, protocols and reports, grant applications) 

Experience

  • Minimum 12 years’ relevant experience, experience in a commercial product registration is a must
  • Proven ability to work effectively in a team environment and matrix structure is critical
  • Experience building and leading teams in a startup environment
  • Proven track record in pharmaceutical drug development

Education

  • Master degree or Ph.D. in relevant field. Diploma in the relevant area of scientific field specific to the product line(s).
  • Business degree or equivalent experience, MBA a plus

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Willingness and ability to travel globally
  • Excellent knowledge of Microsoft Suite

Other information

  • Status:    (Full time – Permanent role)

To apply

  • Deadline for application: Accepting applications until November 26th.
  • Only shortlisted candidates will be contacted.