Quality Control Project Manager (H / F)

Bioprojet; Palaiseau; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Une entreprise pharmaceutique innovante recherche un Responsable Médical pour diriger le développement clinique. Ce rôle clé implique la gestion de la stratégie clinique, la supervision des études cliniques et la collaboration avec des équipes multidisciplinaires. Vous aurez l'opportunité de contribuer à des programmes de développement passionnants, en vous concentrant sur la sécurité des patients et l'optimisation des protocoles cliniques. Rejoignez une organisation dynamique où vos compétences auront un impact direct sur les traitements des maladies rares. Si vous êtes passionné par l'innovation et la recherche clinique, cette position est faite pour vous.

Qualifications

• MD requis, expérience en neurologie ou psychiatrie préférée.
• 3-5+ ans d'expérience dans une organisation CRO/pharma/biotech.

Responsabilités

• Contribuer à la stratégie clinique pour les programmes et études.
• Surveiller médicalement les études cliniques et assurer la sécurité des patients.

Connaissances

Communication verbale et écrite

Pensée critique et créative

Gestion de la sécurité des patients

Connaissance des Bonnes Pratiques Cliniques (GCP)

Gestion de projet

Formation

Médecin (MD)

Description du poste

Dernière mise à jour: il y a plus de 30 jours

Description de poste

Bioprojet is a pharmaceutical company headquartered in Paris. The company was established in 1982 and has its own fundamental research centre, with a vision to provide novel treatment options for people living with rare diseases who have unmet medical needs.

SUMMARY

The Medical Lead, Clinical Development is responsible for leading and driving inputs into clinical development strategy for Bioprojet’s key programs and studies. This role will act as medical lead on these programs as well as sponsor’s safety physician. This role will work closely with Bioprojet’s Clinical Operations team and partner with the lead Clinical Trial Manager and the Clinical Research Organisation (CRO) in the operational delivery of clinical studies. This position offers an exciting opportunity in a growing organization with multiple development programs to provide an impact from the start and then grow as the company builds out its clinical development enterprise.

DUTIES AND RESPONSIBILITIES

1. Contribute to build and manage the clinical strategy lead for clinical programs and studies.
2. Perform clinical studies medical monitoring with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
3. Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
4. Responsible for leading/assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in the areas of interest to Bioprojet Pharma.
5. Draft clinical trial protocols and lead cross-functional teams in the review and efficient finalization of clinical protocols and related clinical documents.
6. Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products of business development opportunities.
7. Provide leadership on cross-functional product development team(s).
8. Participate in identification, selection and conduct of negotiations with clinical research sites and investigators.
9. Participate in the selection and management activities of CROs.
10. Supervise project team members in planning, conducting, and evaluating clinical trials.
11. Drive fiscal responsibility with the operational budget and cost savings initiatives.
12. Maintain compliance with Standard Operating Procedures (SOPs) and policies and perform all duties consistent with Good Clinical Practices (GCP).

QUALIFICATIONS

1. Medical Doctor (MD) required, with experience in Neurology or Psychiatry preferred (Board Eligible (BE) / Board Certified (BC) Neurologist is a plus).
2. 3-5+ years of experience in a CRO/pharma/biotech organization with experience in GCP; pharmaceutical experience is most preferred.
3. 3+ years of Central Nervous System (CNS) clinical research experience with ability to draft clinical development plans, clinical trial protocols and related clinical documents.
4. Experience working in a medical monitor/safety physician role with demonstrated knowledge of review of safety cases and drafting of clinical narratives.
5. Strong verbal and written communication/presentation skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures.
6. High ethical & quality standards demonstrated through actions and communication.
7. Demonstrated ability to work independently and seek guidance when needed.
8. Demonstrated ability to identify opportunities for continual improvement.
9. Must think critically and creatively.
10. Demonstrated experience working within a fast-paced, matrix environment.

LANGUAGE

Fluent English, French would be a plus.

WORK ENVIRONMENT

Position based in Paris. Tele-working is possible 2 days a week. Full-time open-ended contract, starting as soon as possible (part-time also accepted if preferred).

REMUNERATION

To be negotiated + benefits in force in the company.