SVP (Head), Clinical Development | hematology-focused, late-stage, multi-asset, public biotech | newly-created | Boston - RETAINED SEARCH

Cornerstone Search Group; Boston (MA); On-site; USD 350,000 - 600,000; Full time

Job summary

Cornerstone Search Group has been retained by a high-profile, fully-integrated, well-funded public biotech to find an MD for the newly-created SVP, Head of Clinical Development role. The candidate will lead Phase II/III global development, oversee NDA/BLA submissions, lifecycle management, and post-approval studies, reporting to the CMO with a growing Medical Directors/Clinical Scientists team.

The role requires deep late-stage development expertise, strong regulatory experience, and the ability

Qualifications

• MD or equivalent.
• Training or clinical development experience in hematology or heme-onc is a plus; Immunology can compensate.
• 10+ years of industry clinical development experience.
• Pivotal trial track record: planning, initiation, and execution.
• Regulatory filing track record: NDA or BLA experience.
• Prior direct line management experience of Medical Directors/Clinical Scientists.
• Experience presenting clinical strategy and data to executive leadership and BoD.
• Antibody experience is a plus.
• Prior clinical-stage or small pharma experience is a plus.

Responsibilities

• Lead and manage Phase II and III global clinical development activities.
• Oversee NDA/BLA submissions and lifecycle management.
• Direct post-approval studies and long-term safety programs.
• Manage Medical Directors and Clinical Scientists with a focus on high EQ and collaboration.
• Collaborate with CMO and executive team in a fast-paced environment.
• Travel US and globally as needed.

Skills

MD

Clinical development

Pivotal trial planning

Regulatory filings NDA/BLA

Medical director leadership

Hematology experience

Immunology experience

Executive presentation

Travel readiness

Education

MD degree

Job description

SVP / HEAD, CLINICAL DEVELOPMENT [Retained Search]

• 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

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.

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.

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.