HEAD - CLINICAL DEVELOPMENT
The role is responsible for:
 overseeing trials in clinical development and pharmacovigilance according
to agreed-upon deadlines, for
 establishing and maintaining close working relationships with clinical
counterparts and stakeholders and for
 provide the clinical-regulatory landscape for each of the clinical programs.
The Head of Clinical Development will
 act as a cross functional advisor across American Regen functions and
 will partner with internal and external experts in
o clinical practice,
o development,
o pharmacovigilance,
o biostatistics,
o regulatory affairs,
o product and commercial.
Summary Of Key Responsibilities

Provide leadership and guidance for all clinical development activities and
operations to internal/external team members to ensure efficient
execution

Provide strategic direction on a suite of trial designs for each Blue Note
product addressing FDA, clinical practice and payer’s needs

Ensure the timing and sequence of data informs optimal introduction and
commercialization

Lead internal/external study teams through synopsis/protocol development
through final publication

Build the Blue Note team and lead contract research organization (CRO)
interactions and support

Partner with the Access and Reimbursement team on optimal health
economic and outcomes (HEOR) trials to secure conventional coverage and
reimbursement

Partner with Product and Patient Engagement teams to optimize patient
input and testing for prototype products and lifecycle improvements

Prepare clinical portions of prescription digital therapeutics submissions,
including protocols and protocol amendments, investigator brochures, drug
safety update reports, clinical study reports, medical reports, efficacy and
safety summaries, scientific rationales and benefit/risk ratios

Develop and maintain key opinion leader relationships and serve as the
clinical lead for advisory meetings

Establish and maintain relationships with alliance partners,
internal/external stakeholders, investigators and opinion leaders to
optimize performance on clinical trial activities

Prepare manuscripts for technical journals and make presentations at
scientific meetings

Work collaboratively with Research and Development providing input into
design of clinical studies to support our prescription digital therapeutics

Provides input to evaluate products for in licensing/out licensing

Participate in business development & licensing processes as needed

Accountable for clinical portion of regulatory documents such as
Investigator Brochure updates, and Drug Safety Update Reports

Manage and be responsible for pharmacovigilance for clinical projects
including review and reporting

Accountable for medical monitor activities during all Phases through direct
execution of activities or via supervision of others
Qualifications and Skills

At least 10 years of overall relevant experience within
pharmaceutical/biotech industry, healthcare practice and/or clinical
research is required

Understanding of Digital therapeutic/Clinical drug development
experience is essential, oncology experience preferred but not required

Extensive knowledge of basic and clinical science

Understanding of mental health care, neuroscience, and
oncology/hematology

Demonstrated strategic and critical thinking, dynamic leadership and teambuilding skills; as well as the ability to perform effectively in an adaptive
environment

Start-up/small company experience is helpful; willingness to be ‘hands-on’
is essential. This is a player-coach role

The ability to lead directly and by influence, including strong problemsolving, conflict resolution, and analytical skills

Able to facilitate discussions among groups with diverse technical expertise
and varying opinions and drive decisions on complex issues

Proven success leading the creation of clinical components of key
documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures,
Clinical Study Reports (CSRs), regulatory documents including maintenance
of product licenses, registration dossiers, value dossiers, pharmacoeconomic dossiers with high quality and consistency

Previous experience supporting the registration, market access,
commercialization, and product maintenance

Thorough knowledge of Good Clinical Practice, clinical trial design,
statistics, and regulatory/clinical development process

Experience with submissions, IRBs, FDA and international health authorities
required

The statements herein describe the general nature and level of work being
performed by employees assigned to this position and should not be
construed as an exhaustive list of all responsibilities, duties, and skills
required or assigned

TRAVEL: Ability to travel up to 30% of the time as needed