Sr. Medical Director
vor 7 Monaten
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.
**Purpose of this role**:
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.
- 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
- 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.
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