Chief Medical Officer
Our client is a biotechnology company. They have asked us to assist them in a search for a Chief Medical Officer.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Oversees the clinical development campaign for up to 10 clinical stage programs in CNS, Oncology and Virology.
- Leads up to 7 collaborations with our academic and biotech partners.
- Leads interactions with global regulatory agencies, medical congresses and meetings.
- Participates in fundraising, current and potential collaborations, and interacts with external agencies.
- Acts as the chair to our Scientific Advisory Board.
- Leads clinical development programs from late preclinical stage all the way to registration and completion of post-approval commitments.
- Works cross-functionally with clinical operations and vendors to successfully execute clinical trials and natural history studies.
- Coordinates, collects, and analyses clinical data and reporting, and provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Manages the preparation and review of data listings, summary tables, study results, study reports, clinical reports, regulatory and safety documents, investigator brochures, and clinical development plans.
- Interacts with global regulatory agencies and holds responsibility for authoring and reviewing relevant Pre-IND, IND, and BLA sections and generating responses.
- Works collaboratively with senior management to conduct due diligence and assess business development opportunities.
- Collaborates with academic institutions associated with the clinical development program.
- Engages with thought leaders, investigators, cooperative groups and other experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
- Partners with internal and external key stakeholders to develop manuscripts for publication in peer-reviewed journals and prepares presentations for scientific conferences as well as for clinical study investigator meetings.
- Collaborates with Medical Affairs in developing medical slide decks, educational materials, and publication strategy.
- Represents the organization externally where necessary through publications and presentations at scientific meetings and congresses, both domestically and internationally.
- Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
- 10 or more years of clinical development experience, including designing and managing clinical trials, authoring clinical trial protocols and study reports, and developing clinical development strategy is required.
- Must have a Medical Degree with biopharmaceutical industry and translational medicine experience.
- Experience in rare diseases, CNS, and oncology/hematology is preferred, with experience in cell therapy or gene therapy is a plus.
- Requires demonstrated leadership in a clinical development capacity and team building skills as well as the ability to perform effectively in a dynamic and evolving environment.
- Must have excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies and obtaining regulatory approval is preferred.
- Successful submission of INDs and submission of marketing approval-directed filing (BLAs, NDAs, and MAAs) is preferred.
- Requires the ability to create an active network with KOLs, key research centers, patient advocacy groups and a variety of patient care organizations.
- Must have and understanding of statistics and data management considerations for clinical trial design and scientific communications.
- Knowledge of medical monitoring of clinical trials is required.
- Requires strong communication skills to present internally and at scientific meetings, and author medical documents and scientific publications.
- The ability to collaborate with internal and external stakeholders and diverse workforce within a cross-functional matrix environment is required.
- Must have exceptional organizational, analytical, critical thinking, problem-solving abilities, and strong attention to detail while working on multiple projects in a fast-paced, dynamic start-up and scaling environment.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.