Director of Regulatory Affairs at unique early-stage biotech
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.
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
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
Senior Director of Clinical Pharmacology role at biotech
Senior Director of Clinical Pharmacology Wanted - Cambridge-based Biotech Company
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!
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