Context
Home Biosciences (HBS) is a new breed of biotech company, aiming to unlock scientific breakthroughs by leveraging an asset-centric operating model. HBS partners with academics and scientists across Europe to transform their innovation into life changing therapies for patients by assembling the right expertise and structure for each project. Each program is housed in a dedicated entity (a “SPV”), fully financed by HBS and led by teams exclusively focused on the day-to-day execution of its projects, with oversight from HBS’ core management team. HBS operates along therapeutic areas, treatment modalities and technology platforms, and investigates all incoming programs that have life-changing potential in unmet medical needs. HBS’ initial priorities are in the fields of highly debilitating musculoskeletal and metabolic diseases, where there is poor, or no therapeutic option: kidney & bone metabolism, muscular disorders and pain management. Home Biosciences is backed by US-based Redmile Group and France-based Sofinnova Partners, two leading VCs in the field of biotech
Role & missions
Home Biosciences is looking for a Project Manager & Non-Clinical Ops Director. This person will report to the Head of Strategy & Operations. She/ He will play an important role in building the future portfolio of SPVs of the company, from the sourcing of projects, their thorough and efficient evaluation, the crafting of operational roadmaps, the incubation of projects, until the execution of selected activities at SPV level – with a specific focus on all the non-clinical activities.
The candidate will possess a record of demonstrated success in both project management related activities (with the required ability (i) drive a multidisciplinary team, (ii) navigate from details to the ‘big picture’, (iii) provide regular update at the right level to management, (iv) quickly identify areas of risks, …) and non-clinical R&D operations, especially the ability to design pragmatic and actionable non clinical studies to progressively de-risk a program and the experience in managing efficiently CROs and/ or CDMOs.
This broad, hands-on function, will include the following missions:
- Contribute to the sourcing of projects, fostering relationships with selected research institutes / hospitals / patient associations, and ensuring recognition of HBS within the academic ecosystem as a preferred and differentiated partner.
- Lead/ co-lead with the Head of Operations, projects evaluations, due diligences, definition of operational roadmaps.
- Design and execute stepwise de-risking plans related to Safety/ ADME, to enable well informed decision making – working with CROs and experts as needed to generate actionable conclusions.
- Support non-clinical activities at SPV level as needed, collaborating with the SPVs’ operational teams – contribute to non-clinical roadmap design and review, to the selection of CROs.
- As needed, lead specific market studies or disease/ technology landscaping as part of Home Biosciences’ portfolio strategy or as part of the evaluation of a specific SPV opportunity – with required combination of scientific, medical, development, business perspectives.
- As needed, act as project manager for a project during its incubation phase to oversee and coordinate work across academic partners, CROs, experts, and/or during initial period of SPV creation, ensuring proper hand over to SPV team once recruited.
Main Responsibilities
- Contribute to crafting of HBS’ SPVs’ operational roadmaps and business plans, including necessary updates.
- Contribute to the elaboration and execution a rigorous, pragmatic and informative non-clinical strategies (pre regulatory as well as regulatory packages) during the incubation/ maturation phases – in collaboration with Research / scientific teams.
- Anticipate any unplanned event at SPV level requiring key decisions at HBS level and support thr decision-making process assessing relevant options and evaluating the impact of necessary changes (significant change vs plan).
- Contribute to drive HBS culture of transparency, collaboration, delivery of priorities, rigorous execution and risk management, both at HBS and SPV level.
- Represent the company vis a vis academic partners (TTOs), scientists, CROs, CDMOs, experts & consultants.
Education and Experience, other important criteria
- Dual background – scientific (PhD, MD, PharmD) and industrial (Biotech and/or Pharma R&D operations experience, especially in the field of non-clinical activities) – min 10 years experience.
- Track record demonstrating ability to deliver, to advance a project from preclinical to IND, to drive CROs, to support internal decision making (one or several of those achievements).
- Expertise in regulatory affairs and / or CMC is a plus.
- Ability to navigate in a start-up/ moving environment, appetite in new ventures building, in working across multiple therapeutic areas and therapeutic modalities.
- Rigor, transparency, solution driven.
- Strong interpersonal skills & collaborative mindset.
- Ability to manage and drive multidisciplinary teams.
- Strong communication skills – ability to adapt to multiple stakeholders (Scientists, clinicians, tech transfer from academic centers, CROs, consultants, KOLs and physicians, …).
