Director of Clinical Development for Immunology (MD)
Role & Responsibilities
Reporting to the Vice President of Early Clinical Development, the Director of Clinical Development for Immunology will be responsible for the development and implementation of small molecule clinical programs in the therapeutic areas of immunology/inflammation and oncology at Nimbus. We are seeking a highly motivated, collaborative, results-oriented individual with the creativity, resourcefulness, and flexibility to excel in a growing company.
More specifically, the person in this role will:
- Develop programmatic clinical strategy and plans; oversee implementation of clinical programs in line with the clinical strategy and ensure patient safety and data integrity
- Drive and/or oversee the design, execution, analysis, interpretation, and reporting of clinical studies, both early and more advanced, in collaboration with R&D team members, in a matrixed and highly collaborative team environment
- Serve as a Medical Monitor for early (clinical pharmacology, including first in human, DDI, proof of mechanism/concept) to mid-stage and registrational clinical studies
- Assess trade-offs and build alignment with team members to enable informed programmatic decision-making
- Support development and implementation of program biomarker plans and ensure successful implementation at study site(s)
- Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions
The Qualifications We Are Seeking
- M.D. or M.D., Ph.D. with a minimum of 5 years of relevant experience in biopharmaceutical industry, including significant small molecule drug development experience
- Educational background in a relevant scientific discipline (e.g., biology, biochemistry, immunology) and advanced degree(s), including as Doctor of Medicine and post-graduate medical or scientific training; specific therapeutic experience in oncology, immunology, and/or immuno-oncology
- Prior experience as a functional leader (e.g., early clinical development, clinical pharmacology, experimental medicine, clinical development);
- Broad understanding of biopharmaceutical drug development, including working knowledge of relevant ICH and GCP guidelines and regulations
- Passion and proficiency in developing and nurturing key partnerships and collaborations with external parties, including investigators, KOLs, CROs, and the broader scientific community (including academia, governmental, or nonprofit organizations), as well as internal discovery and preclinical functions
- Record of significant and successful contributions to regulatory submissions, including INDs/CTAs, and regulatory agency interactions
- Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirable
- Aptitude and interest in serving as a subject matter expert across the organization
- Excellent written and oral communication skills; experience delivering effective presentations to both technical and non-technical audiences
A Snapshot of Nimbus
Nimbus is a ~ 40 person, biotechnology company located in the thriving biotech hub of Cambridge, Massachusetts. We transform drug development by integrating computational drug discovery techniques, a cutting-edge computational chemistry platform and other advanced technologies to design breakthrough medicines for patients.
We focus on promising targets in metabolic disease, oncology and inflammation. These include both emerging and well-validated targets that have proven intractable to others in the pharmaceutical and biotechnology industry.
Nimbus offers a fast-paced, entrepreneurial, team-focused work environment. The culture is intellectually stimulating, flexible and results-oriented. Joining our Team offers significant opportunities to grow professionally and personally.
We also offer a top-notch benefits package (health, dental, life, vacation, and employer 401K contribution). Being part of Nimbus (a Nimbi, if you’re curious), allows you to become part of a small close-knit professional team that strives to bring out the best in each other by working hard and having fun together (company lunches and outings, running, rocking and even bowling from time to time!)
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.