Director/Senior Director, Clinical Development
- Employer
- Formation Bio
- Location
- New York, NY
- Start date
- Jul 1, 2022
View more
- Discipline
- Clinical, Clinical Development, Clinical Research
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country
Job Details
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 is building 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.
Company
Formation Bio is a tech-driven pharma company differentiated by radically more efficient drug development. Formation Bio has built a technology platform that optimizes all aspects of drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data capture.
Formation Bio acquires clinical-stage drugs from pharma and biotech and develops them faster and more efficiently, unlocking greater value per program and accelerating access to new treatments for patients.
Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.
- Website
- https://www.formation.bio/
- Phone
- +1 510-545-3803
- Location
-
16 East 34th Street floor 10
New York
NY
10016
United States
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