Medical Director, Clinical Development - Boston, United States - Nimbus Therapeutics

Nimbus Therapeutics

Verified Company

Boston, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Nimbus has an outstanding opportunity for an Medical Director, Clinical Development to join our team. This person will serve as the primary Medical Monitor on a first-in-human study, establishing all the relevant relationships with site staff, CRO and relevant vendors. They are responsible for the safety of clinical trial participants throughout the study, including chairing dose escalation decisions, review and interpretation of data and provide clinical leadership to a cross-functional team at Nimbus. You will report to our Senior Vice President, Oncology Development.

In This R
ole Y
ou Will**:

Lead the design, execution, and analysis of earlytomid phase Oncology / Immuno-Oncology studies
Serve as medical monitor and representative to multiple vendors and collaborators including CROs, PIs, and core laboratories, ensuring patient safety and data integrity
Support development and implementation of translational/biomarker plan to ensure successful implementation at study sites
Collaborate closely with internal research teams to integrate translational research and clinical strategies
Author clinical portions regulatory submissions, safety reports, responses to regulatory authorities, and other documents as appropriate
Establish strong collaborations with study investigators, outside medical experts and represent Nimbus during investigator meetings and advisory boards
Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP)
Ensure scientific rigor and innovation is integrated into and drives Company's development strategies
Contribute to the development of strategic initiatives, specific Business Development activities, and various organizational initiatives in Clinical Development

These Qualifications Will Help This Role Be Successful**:

MD or MD / PhD. with 3+ years of relevant experience in biopharmaceutical industry, including early phase (FIH) drug development experience within Oncology therapeutic area. Immuno-Oncology experience preferred but not required
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
Excellent written and oral communication skills; experience delivering effective presentations to both technical and nontechnical audiences
Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
Ability to navigate, problemsolve, execute, and lead in a dynamic, fastpaced and evolving environment

A Snapshot of Nimbus

Our _S_cience_

At Nimbus, we design breakthrough medicines.

Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle.

With a decade-plus track record of success, we've built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.

Our _C_ulture_

Nimbus is a close-knit company (our employees are Nimbi, if you are curious) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment.

We live by our Core Values:

Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.