Director, Clinical Development- Rheumatology

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. 

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others. 

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

Achieving this goal of the growth of Formation Bio 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 product assessment 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 and monitor 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 Formation Bio.  In addition, the ability to work effectively in a matrix environment and to communicate efficiently 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 manner 

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

About You

• At least 1-3 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
• Experi