Job Description

GeneCoda has been retained to identify and evaluate candidates for a Chief Medical Officer (CMO) to onboard in late Q2 or early Q3 of 2023 and to be located in the Research Triangle Park, NC.

Some relocation assistance can be provided for candidates not already located in the region. Learn why the RTP, NC area as a global life sciences leader might be the right choice for you!

About Our Client:

Our client is an innovative drug development company leveraging machine learning techniques to redesign and optimize drug candidates for known and well validated drug targets.

Narrative:

Our client’s platform enables them to identify novel and better drug candidates based on information from products that have failed in the clinic.

Reporting to the CEO, our client is seeking an accomplished CMO with expertise in leading IND filings and early clinical studies. The CMO is responsible for providing clinical guidance on strategic and operating decisions. The CMO also oversees the execution of clinical trials, including regulatory filings. The ideal candidate will have filed several IND’s and be an expert in Phase 1 trial designs.

Initially, the CMO will work on readying our client’s lead asset for a pre-IND meeting in mid-2023 and designing the protocol for the first clinical asset.

Key Responsibilitie s:

Clinical Trials

• Leads and oversees the tactical development of clinical trial programs, including investigator’s brochure, protocol writing, CRO selection and trial execution.
• Oversee the analysis and interpretation of clinical trial data, the reporting of clinical trial results and literature reviews.
• Supports clinical development strategies including Phase 1 through 3 and lifecycle management.
• Responsible for medical affairs, safety oversight and reporting
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with regulatory bodies.

Clinical Operations

• Manages and supports the clinical operations team to reach their objectives.
• Provides medical monitoring support as required including support/supplement of CROs’ physicians.
• Medical monitoring of active trials where full service CROs are not providing medical monitoring support.
• Designs, writes, and executes clinical study protocols in collaboration with project management, including proactive detection of operational issues and proposed resolutions.
• Supports the selection of clinical CROs.
• Reviews submissions to ethics committees and competent regulatory authorities; provides clinical input into responses to any questions/issues raised and in support of operational teams.
• Provides input into ICF and IND development and submission as well as advertisements and patient recruitment and retention strategies.
• Provides clinical input into data management, data validation specifications, and statistical analysis plans.
• Oversees and provides input into eCRF development, query generation and resolution.
• Collaborates with CROs and their staff for regular support of clinical investigators.

Clinical Strategy

• Attends appropriate scientific meetings.
• Supports the publication strategy for clinical data and participates in discussions on preclinical data (lead selection of journals, authors/presenters, timelines).
• Supports the writing of clinical abstracts, posters, presentations, and manuscripts.
• Ensures submissions to appropriate meetings/journals.
• Keeps abreast of the critical evolution of therapeutic options for chosen therapeutic indications and alerts the CMO, Senior Management and clinical operations staff to evolving management paradigms.

Business Development Strategy and Operations

• Supports Business Development with respect to in licensing/out licensing opportunities.

Education: MD with an active US medical license and completion of a US residency or fellowship. Board Certification in Internal or Family Medicine is a plus.

Experience and Qualifications:

• Minimum 10+ years experience in pharmaceutical development in Phase 1-3 clinical trials.
• Hands on experience in designing, executing, and monitoring Phase 1-3 trials.
• Clinical experience in one or more therapeutic areas including neuroscience, metabolism, and oncology.
• Ability to manage multiple clinical trials at different stages in several programs as required.
• Demonstrates ability to manage staff, partners, and operational details of clinical trials. Hands on site inspection and medical writing.
• Experience selecting and building strategic relationships to support the requirements of the role.
• Experience in interactions with FDA personnel is essential, other health authorities a plus.

Desired Characteristics:

• Strong collaborative skills. Team player mentality.
• Effective decision-making and problem-solving skills.
• Able to handle complexity and ambiguity as well as be able to prioritize, organize and manage multiple projects simultaneously.
• Excellent interpersonal skills.
• Excellent verbal and written communication skills.

GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.

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