Director, Clinical Development Oncology

Company: ElevateBio
Location: Waltham
Posted on: September 12, 2020

Job Description:

Title: Director, Clinical Development Oncology

Location: Waltham, MA

Reports to: Vice President, Early Development

The Role:

The Director, Clinical Development Oncology, will be responsible for the development strategy, design and execution of Phase I/II clinical trials conducted by ElevateBio. The role will involve all aspects of clinical trial design and conduct, and work with CRO partners, clinical trial sites and internal and external subject matter experts to design, conduct, and reporting clinical trials to meet corporate goals and timelines.

Here’s What You’ll Do:

Design Early Development Strategies for novel oncology cell and gene therapies, including providing clinical input to target patient profiles for assets

Design and serve as internal physician monitor for Phase 1/2 clinical trials of novel cell and gene therapies

Establish strong partnerships with external physician investigators at trial sites, Contract Research Organizations (CROs) and internal team members to successfully execute Phase I/II clinical trials

Interact with external physician experts to obtain input for clinical strategies and execution of clinical trials

Represent clinical development at regulatory interactions as physician expert; contribute to preparation of regulatory documents

Provide input as clinical expert for business development activities and potential partnerships

Serve as the clinical expert for the internal development team, clinical trial team and the joint development team with asset partners

Provide input to Phase I/II clinical trial planning and budgeting for internal studies and internal assessments for studies conducted externally through scientific partners

Build and maintain strong working relationships with operations lead, program manager, scientific lead, internal departments and external partners

Proactively identify risks, gaps and resource bottlenecks, and work with internal and external partners to develop and implement mitigation plans

Requirements:

MD or equivalent, with clinical training in oncology

3+ years of experience in biomedical industry with responsibilities including the design, execution and/or conduct of clinical trials. Experience in oncology preferred; experience in cell/gene therapy not required but preferred. Candidates with more experience are welcome and the title and responsibilities will be commensurate with industry experience

Experience with co-diagnostics preferred but not required

Clinical strategy development experience preferable

Experience in preparation of documents for regulatory meetings and attending regulatory meetings with the US FDA and other regulatory agencies

Experience as clinical expert on cross-functional clinical development and clinical trial teams

Experience working directly with clinical trial sites and with CROs

Excellent scientific writing and presentation skills

Experience interacting with external physician experts

Strong communication skills with ability to build professional relationships with external and internal stakeholders

Strong understanding of US FDA, and ex-US regulations, and ICH guidelines for clinical trials, and ability to learn guidelines pertaining to cell and gene therapy products

Flexibility and comfort working in a young and growing organization; excited to contribute to creating an organization

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:

Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Keywords: ElevateBio, Waltham , Director, Clinical Development Oncology, Other , Waltham, Massachusetts