Director, Clinical Development - Cardiovascular

About Formation Bio

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

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.

About the Role

Achieving this goal of the growth of Formation Bio will require an energetic, highly motivated, experienced and creative world class Clinical Development Team. We need you to be part of that journey:  As a key member of  the Clinical Development team as the project physician, you will be responsible for providing strategic clinical  input to the development and execution of the Clinical Development plan in cardiovascular diseases. This would include activities such as  protocol development and medical monitoring.

A key success factor for Formation Bio is our desire to make drug development even more efficient through incorporation of tech and AI to our daily work. Therefore, your ability to understand and navigate the complexities of healthcare data and clinical trials and partner with the tech team to develop tools for the development process 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, particularly related to the deployment of AI .

Responsibilities

Clinical Development Planning and Execution: 

• Development of protocol concepts, protocols and Clinical Development plans 
• Clinical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy considerations as well as commercial needs.
• Based on the clinical trial design landscape contribute to study design and planning strategy
• Medical monitoring and oversight of phase 2-4 trials

Operational Excellence:

• Partner with the Development Operations team to develop innovative ways to ensure excellence in study execution, particularly around the deployment of tech solutions Drive/contribute to trial operations and medical processes to achieve continued innovation and improvement
• Partner with the Development Operations team to conduct feasibility and asses the suitability of sites  for the particular studyInput into patient recruitment tools
• Maintain close relationships with the sites to provide input for innovative recruitment ideas.  
• 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.

AI and Tech deployment

• In partnership with the Development and Tech Teams provide input to the development of  AI tools to ensure we achieve our goal of being a tech enabled drug development company of the future.

Business Development:

• 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 cardiovascular therapy area strategy

About You 

• At least 5 years experience in biotech (preferred) or pharma to include preparation of the Clinical Development Plan, 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 or Cardiology 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

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $270,000 - $340,000.

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

If this range doesn’t match your expectations, please still apply because we may have something else for you.

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.