Director/Senior Director, Clinical Development

| Greater NYC Area | Hybrid
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About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by  in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

Description

Achieving this goal of the growth of TrialSpark will require an energetic, highly motivated, experienced and creative world class Medical Team. We need you to be part of that journey:  As a key member of the team, based on your clinical development experience you will be responsible for providing medical input into our Business Development strategy and execution, lead the development of the Clinical Development Strategy and Plans, including protocol development, for clinical studies.  As part of this responsibility you will provide strategic input to the execution of clinical studies as a project physician.

Your ability to understand and navigate the complexities of healthcare data and clinical trials will be essential to your success and the success of TrialSpark.  In addition, the ability to work effectively in a matrix environment and to communicate effectively across multiple stakeholders is essential.  It will also be essential that you are a creative problem solver with the ability to drive new ways of doing drug development.

Responsibilities

Clinical study planning and execution 

  • Development of protocol concepts, protocols and clinical development plans 
  • Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy considerations as well as commercial needs.
  • Medical monitoring and oversight of phase 2-4 trials


Business development

  • Provide medical input to business development candidates 
  • Direct participation in calls with potential licensing candidates 
  • Work closely with the BD team to develop deal models through your experience in clinical development 
  • Based on review of the scientific landscape contribute to therapeutic areas strategy
  • Based on the clinical trial design landscape contribute to study design and planning strategy

Operational excellence

  • Drive/contribute to trial operations and medical processes to achieve continued innovation and improvement
  • Utilize your clinical development and trial execution experience to develop creative ways to speed up clinical trials in an efficient and 

Training

  • Clinical training for internal stakeholders and clinical trial sites  (e.g. overviews of specific disease areas, drug mechanisms of action, protocol requirements, etc.

Patient recruitment

  • Input into patient recruitment tools
  • Ideas for recruitment strategies - i.e. creative ideas for where we can find patients

Key Qualifications

  • At least 5 years experience in biotech (preferred), pharma or CRO to include protocol development and medical oversight/monitoring of phase 2-4 studies (final title to be determined by experience level)
  • MD/DO degree (or equivalent) required
  • Board certified by accredited speciality board - Internal Medicine preferred
  • Experience with health authority interactions and contributions to regulatory filings preferred
  • Excellent written and verbal communication skills
  • Strong analytical skills
  • A “roll-up-your-sleeves” attitude
  • Track record of cross functional leadership 

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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Technology we use

  • Engineering
  • Product
  • People Operations
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases
    • LookerAnalytics
    • FigmaDesign
    • MiroDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • JIRAManagement
    • SlackCollaboration
    • ZoomCollaboration

Location

Our office is located in Manhattan, near the Empire State Building. The area is lively and has great food and transportation options!

An Insider's view of Formation Bio

What’s the vibe like in the office?

The space is very open which makes it easy to collaborate and engage with different teams across the organization. People are very welcoming, supportive, and friendly. There is always a variety of different food and drinks available in the kitchen, in addition to foods that co-workers bring in for everyone to taste!

Joseph Frappaolo

IT Support Technician

What projects are you most excited about?

The project that excites me most is our new hire onboarding program because of the impact it will have on our company. Though we have a robust onboarding program in place already, we have the opportunity to think creatively about how to make the experience even better for our new hires, from the moment they accept our offer.

Erin Siegel

Senior People Operations Manager

How has your career grown since starting at the company?

I started working at Formation Bio in July of 2018. I joined the company as a Clinical Research Coordinator and was allowed to grow and adapt into new roles as the company's business model shifted. I transitioned into working as a Clinical Trial Associate after a couple of years, and now have over a year of experience as a Clinical Project Manager!

Gurpreet Singh

Clinical Project Manager

How has your career grown since starting at the company?

Formation Bio has given me the opportunity to take ownership over big projects and work streams, allowing me to have an impact on key functional business areas.

Maya Dongier

Senior Accounting Manager

What are Formation Bio Perks + Benefits

Formation Bio Benefits Overview

Formation Bio is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Culture
Open door policy
Open office floor plan
Employee resource groups
Hybrid work model
Flexible work schedule
Diversity
Mandated unconscious bias training
Diversity employee resource groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental insurance
Vision insurance
Health insurance
Life insurance
Financial & Retirement
401(K)
Company equity
Pay transparency
Child Care & Parental Leave Benefits
Generous parental leave
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Office Perks
Company-sponsored outings
Yearly retreat and holiday party, regular team events and outings!
Free snacks and drinks
Company-sponsored happy hours
Fitness stipend
Home-office stipend for remote employees
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Continuing education stipend
Virtual coaching services

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