New Delhi, India
[Closing date: August 6, 2017]
DNDi employs a collaborative R&D model to achieve its mission, in which product development and the supply of investigational products are executed entirely through an external network of pharmaceutical company partners, contract development and manufacturing organizations (CDMO), and expert consultants. During the later stages of clinical development, DNDi seeks industrial partner organizations who, as future license holders, will assume full responsibility for the manufacturing and distribution of the commercial product.
Opened in 2004, the DNDi India office supports the implementation of various R&D projects. The main focus is on visceral leishmaniasis along with activities in hepatitis C, filariasis, and paediatric HIV. The office also works closely on raising awareness and advocating for increased public responsibility and a more enabling environment for neglected disease R&D.
As part of ongoing organizational development, DNDi is seeking a consultant to landscape and prioritise potential new CDMOs and industrial partners in India, with the ultimate objective of achieving ‘end to end’ development and registration of new chemical entities.
Purpose of the position
The consultant will report directly to the Director of DNDi Regional Office India, whilst working closely with assigned colleagues to deliver the project. In addition, s/he will be expected to establish and maintain effective working relationships with a range of external CDMO, industrial partners and expert consultants.
Specific job responsibilities
The consultant will be responsible for:
- Developing qualification criteria for CDMO and industrial partners in terms of technical capabilities and capacity, quality and regulatory standards, motivation towards neglected tropical diseases, business requirements etc.
- Conducting a systematic survey of potential CDMO and industrial partners in India and prioritizing these organizations against the qualification criteria.
- In collaboration with the Director of Business Development and the Head of Pharmaceutical Development, liaising with and performing in-depth evaluations of the prioritized candidates, participating in meetings, site visits etc.
- Developing and maintaining a suitable project schedule and budget.
- Preparing project updates, presentations and reports for internal stakeholders (e.g. DNDi senior management, DNDi Board).
- Making final recommendations to the Director of DNDi Regional Office India, the Director of Business Development and the Head of Pharmaceutical Development.
- Responsible for managing the project to agreed timelines and financial targets.
- No direct reports.
Skills and attributes
- Robust knowledge of pharmaceutical development/CMC activities, quality and regulatory requirements, and their relationship to the R&D process for new chemical entities.
- Excellent awareness of the current CDMO and pharmaceutical industry environment in India.
- Demonstrated project management skills and strong track record of project delivery as a consultant.
- Ability to interrogate and interpret data, make sound decisions and recommendations.
- Capacity to plan and organise own work with autonomy.
- Evidence of effective interpersonal skills and collaborations across different organizational levels and boundaries.
- Strongly supportive of the DNDi mission and vision, and understanding the organization’s values and business model.
- Competent in use of spreadsheet and planning software.
- Good oral and written communication skills in English – knowledge of additional languages would be an asset.
- Substantial experience in R&D outsourcing and business development.
- Advanced degree in relevant scientific discipline (e.g. chemistry, chemical engineering, pharmacy); business qualifications highly desirable (e.g. MBA).
- The position is a short-term contract of 6 months’ duration at 50% starting in September 2017.
- The role is based in India and involves regular travel.
- Deadline for application: Accepting applications until August 6th, 2017.