SVP (Head), Clinical Development
Description
- Newly-created position to lead a transatlantic team planning and managing all assets starting in Phase II and taking them through pivotal trials, NDA/BLA submission, lifecycle management, and post-approval studies
- Hematology-focused, fully-integrated, late-stage, well-funded public biotech
- Multiple clinical-stage assets featuring wide variety of modality types
- Clinical indications addressing rare, ultra-rare, and non-rare (mass market) diseases
- Company intends to commercialize in US and globally
- Report to a positive-minded, personable, and experienced CMO
- Leadership team is highly regarded and has strong relevant TA experience with successful biotechs and pharmas
- Boston metro area (3 days/week onsite)
SUMMARY: Cornerstone Search Group has been retained by a high-profile, fully-integrated, well-funded, public biotech with a multi-asset, late-stage pipeline for a newly-created SVP, Head of Clinical Development position. This biotech is focused on discovering, developing, and globally commercializing transformative therapies across a range of related rare, ultra-rare, and mass-market disorders that have long lacked meaningful treatment innovations. They have in development multiple first-in-class pipeline assets that utilize multiple small and large molecule modalities. They are now seeking an MD with strong industry late-stage clinical development and NDA/BLA submission experience who ideally has training or industry experience in Hematology, Hematology-Oncology, or Immunology.
Location
Boston, MA Metro Area (3 days/week on-site)
Responsibilities
This position reports to the CMO and will lead and manage a growing team of Medical Directors and Clinical Scientists responsible for all Phase II and III global clinical development activities, NDA/BLA submissions, lifecycle management, and post-approval studies. The personable and experienced CMO is looking for an MD who thrives in a smaller company environment, has strong emotional intelligence, is highly collaborative, and innovative in their approach.
Qualifications / Requirements
DESIRED SKILLS / QUALIFICATIONS / EXPERIENCES / BEHAVIORS:
- MD or equivalent.
- Training or clinical development experience in hematology or heme-onc is a plus. Depth in other TA late-stage development experience, particularly in Immunology, can compensate.
- 10+ years of industry clinical development experience.
- Pivotal trial track record: planning, initiation, and execution of pivotal trial(s).
- Regulatory filing track record: NDA or BLA experience. EMA and other regions are a plus.
- Prior direct line management experience of Medical Directors / Clinical Scientists.
- Experience presenting clinical strategy and data to executive leadership and BoD.
- While the company works in multiple modalities, antibody experience is a plus.
- Prior clinical-stage or small pharma experience is a plus.
- High EQ, low-ego, transparent, and authentic leader who thrives in fast-paced, dynamic environments and is comfortable with ambiguity.
- Flexibility to travel US and globally as needed.
Contact
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