Blue Note is looking for the clinical development talent to help us become a category-defining cancer company in 2021. Blue Note has a portfolio of products and a suite of registrational, label expansion and health economic/outcomes trials in development and execution. We have an immediate need for a Head of Clinical Development to provide strategic and technical leadership for our suite of clinical development efforts including: clinical-regulatory development; oncologic, mental health and neuroscience clinical trial design, implementation and execution; clinical data analysis and management; biostatistics; and clinical competitive intelligence.
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 providing the clinical-regulatory landscape for each of the clinical programs. The Head of Clinical Development will act as a cross functional advisor across Blue Note functions and will partner with internal and external experts in clinical practice, development, pharmacovigilance, biostatistics, regulatory affairs, 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 team-building 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 problem-solving, 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, pharmaco-economic 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
Certifications and/or Licensure
- Board certification in internal medicine desired; subspecialty certification in Oncology (and/or Hematology preferred)
Education and/or Experience
- Minimum of 3 years’ relevant industry experience in clinical development for FDA/EMA/PMDA authorizations is required
- MD, PhD or MD / PhD credentials or equivalent
Computer Skills
To perform this job successfully, an individual should have knowledge of Google/Microsoft software applications, internet capabilities, virtual team applications. Individual should have a working knowledge of electronic data capture (EDC) systems and optimal configurations.
Physical Demands/Work Environment
While performing the duties of this Job, the employee may be regularly required to sit; stand or remain stationary for extended periods of time and use hands and fingers as well as talk and hear. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.
Requirements for Remote Work:
- A quiet workplace to perform work duties and participate in virtual meetings
- Must live in a location that can leverage an existing reliable high-speed internet and phone service
- Minimum upload speed 5 MB/s, preferred upload speed 25 MB/s
- Minimum download speed 25 MB/s, preferred download speed 50 MB/s
- Candidates must provide and meet all technical requirements prior to the first day of work
We are Blue Note Therapeutics
Blue Note Therapeutics is a prescription digital therapeutics company singularly dedicated to transforming mental health care for cancer patients. We aim to make mental health care available to any cancer patient at any time by merging deep scientific and clinical expertise, neuroscience, and digital innovation. Working closely with leading cancer centers, community oncology clinics, and teams of patients, Blue Note is developing clinically validated prescription digital therapeutics to help reduce anxiety, depression and other distress related to cancer.
To apply, please send your CV to jobs@bluenotetx.com.
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