Jobs

Our client is forefront of pioneering discoveries in the field of neurology. They are dedicated to making a difference in the lives of patients by harnessing the power of data and innovation. Now, they are looking for a Director of Biostatistics to join their talented team and make a lasting impact.

As a Director of Biostatistics, you will be at the helm of their clinical research endeavors, driving progress and making a significant contribution to the world of neurology.

Your responsibilities will include:
Interpreting and analyzing complex data with finesse.
Juggling multiple projects effortlessly, without dropping the ball.
Communicating exceptionally well, especially with complex data and visualizations.
Collaborating seamlessly with diverse teams.
Influencing biotech's approach to managing clinical trial data.
Representing Biostatistics on core project teams for operational and strategic decisions.

What You Bring:
We're seeking a dynamic and hands-on Biostatistician who can bring their expertise to the front lines of our client's groundbreaking clinical research.
You should be a Statistical Maestro: You make data sing and dance to your tune.
A Project Juggler: Handling multiple projects simultaneously is second nature to you.
A Communication Virtuoso: You excel at simplifying complex data and visualizations.
A Collaborative Guru: Working seamlessly with diverse teams is your superpower.

We represent a dynamic and unique early-stage biotech company looking for an experienced regulatory strategist to lead global regulatory activities. As a Director of Regulatory Affairs, you'll be pioneering the "unpaved" road within regulatory and working on exciting early-stage programs and nonclinical/discovery programs that could be game-changers for patients.

We need someone who's not afraid to take risks and push the boundaries of what's possible. You'll be working with a team of dedicated scientists and professionals who are passionate about advancing novel therapies in the oncology or immunology space. As a global regulatory lead, you'll be instrumental in bringing these innovative programs to the clinic and pushing them beyond development.

The ideal candidate will have a deep understanding of the regulatory landscape and be experienced with INDS and etc. We're looking for someone who's based in Massachusetts, ideally within the Greater Boston area, or willing to relocate with the company's support.

If you're someone who thrives on the "early stuff" and loves pursuing targets that have the potential to change patients' lives, we want to hear from you.

Key Responsibilities:

Provide regulatory strategic input and guidance to the development programs
Develop and implement global regulatory strategies for clinical and nonclinical programs
Prepare and submit regulatory filings (INDs, CTAs, BLAs, etc.)
Represent regulatory affairs in cross-functional project teams and external collaborations
Provide leadership and mentorship to the regulatory team
Qualifications:

Extensive regulatory affairs experience in the biotech/pharmaceutical industry
Strong experience with INDS and demonstrated success in leading programs from nonclinical to clinical development
Experience in oncology or immunology preferred
Bachelor's degree in a scientific discipline, advanced degree preferred
Excellent communication, leadership, and project management skills
Ability to work collaboratively in a fast-paced and dynamic environment

Are you a seasoned leader in Clinical Pharmacology with a passion for developing innovative therapies? Look no further! Our fast-growing and financially well-backed biotech company is seeking a Senior Director to lead our Clinical Pharmacology team.

In this role, you will have the opportunity to:

Lead the design and execution of clinical development plans for our pipeline of products
Collaborate with cross-functional teams to drive decision-making and strategy
Mentor and develop a high-performing team of clinical pharmacologists
Represent the company in interactions with external partners and regulatory agencies
The ideal candidate will have:

A Ph.D. or PharmD in Clinical Pharmacology or related field
A minimum of 8 years of industry experience, with at least 3 years in a leadership role
Strong knowledge of FDA regulations and guidelines
Proven track record of successfully leading clinical development programs
Join our dynamic and innovative team in Cambridge and take the next step in your career by applying today!