Sr. Medical Director - Apraglutide

VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need.

VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients.

Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

The Company’s lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, is in Phase 3 to treat patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine.

Apraglutide is also in Phase 2 for the treatment of acute graft-versus-host disease (GVHD).

Purpose of this role :

As Sr. Medical Director you will be a key member of the interdisciplinary development team contributing effectively and independently to clinical development of assigned assets.

This is a high visibility leadership role directly reporting to the Head of Clinical Development, Basel Site. The successful candidate will integrate clinical and research expertise with leadership skills to advance Ironwood’s clinical development strategy including supporting regulatory approval,

You will be responsible for representing clinical science in study management teams, training internal and external staff and responding to health authority requests related to the clinical development plan.

You will be expected to be the expert on assigned protocols. Additionally, you may lead clinical science activities in paediatric development of apraglutide and contribute to plans for further expansion into other indications.

Organizational Home :

This role is located in Basel, Switzerland (remote) or in Boston, USA (remote)

Major Accountabilities :

• Clinical development team participation, both as individual contributor and medical leader : Create and guide clinical development strategy and formulate Clinical Development Plan (CDP), may be leading cross-functional team to evaluate and integrate regulatory, safety, and timeline considerations.
• Study design, conduct, and interpretation : Contribute to preparation of key study documents, including but not limited to study protocols and amendments, statistical analysis plans, clinical study reports, regulatory filing documents.
• Contribute to sponsor oversight of clinical trial execution, ensuring data quality and subject safety through trial medical monitoring or medical oversight of the studies and CROs.

Assess impact of results on the development strategy, and present conclusions to management.

Interactions with external stakeholders : Assess and support the logistics and execution of clinical and preclinical research aligned to the clinical development or medical affairs strategy, including external research collaborations and investigator-initiated research.

Support the scientific communication and publication strategy. Contribute to interactions with regulatory agencies, such as reporting requirements (e.

g., DSUR, INDSRs, etc.) and regulatory submissions.

Profile (Skills, experiences, and qualifications required for the job)

• MD, with prior clinical development experience in the pharmaceutical industry at minimum 5 years
• Preferably board certified (or foreign equivalent) in Gastroenterology and / or Hepatology, Internal Diseases or Pediatrics, but candidates with backgrounds in with other medical specialties who have sound clinical research experience will be considered
• Proven knowledge of clinical research methodology and biostatistics principles, Ability to analyze and interpret clinical and efficacy data and develop formal written reports and presentations of those data internally and externally.
• Demonstrated experience in managing complex projects, and polished skills in influencing, communicating, and working collaboratively with diverse stakeholders
• Adaptable team player able to work independently, exhibit sound judgement, and hold self and team members accountable in meeting timelines.
• Excellent written and oral presentation skills.
Il y a plus de 30 jours