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:
- Leads company’s efforts across clinical development, clinical operations, medical affairs, drug safety, regulatory affairs, and quality assurance.
- Provides strategic and operational guidance on corporate R&D playbook.
- Collaborates with potential or current global pharmaceutical partners to ensure products are properly positioned in designated regions.
- Serves as company spokesperson for all clinical/medical related matters to BOD, investors, and broader financial ecosystem.
- As a part of senior management, plays a key role in advancing corporate vision/strategy and executing on mission critical goals in a highly collaborative manner.
- Conducts leadership activities to enhance company culture. Fosters an innovative environment with the purpose of advancing company’s patient focused objectives.
We seek candidates with the following qualifications:
- Drives the development of clinical development plans, clinical concept sheets and protocols, confidential information brochures, data analysis plans, clinical study reports, and clinical sections of regulatory submissions (IND, CTA, and CTD).
- Creates and encourages an environment that stresses open, candid, and timely feedback relative to performance.
- Leads clinical development strategy and processes within the company to ensure efficient, high quality therapeutic development programs, based on rigorous scientific, medical, and regulatory standards.
- Drives drug safety and pharmacovigilance activities.
- Leads clinical operations, including clinical trial conduct and data collection and optimally leverage internal and contract resources.
- Represents and manages the company’s clinical programs to KOLs, patient organizations, and other appropriate parties in the medical community.
- Leads all clinical related communication with FDA and global regulatory bodies.
- Maintains understanding of the clinical and scientific developments in the transplant area by attending scientific meetings and tracking the literature.
- Represents the clinical and medical groups externally in scientific presentations, conferences, and industry groups, and builds partnerships and relationships with the relevant scientific and medical communities.
- An MD or equivalent is required.
- Prior training and/or industry experience in rare disease, orphan disease, inflammation or pulmonology is required.
- Requires deep expertise in clinical development with proven track record filing and winning approval for orphan disease therapies.
- Exposure to commercial planning for launch and life cycle management activities is highly preferred.
- A mix of small and large company experience is highly preferred.
- Must have significant experience leading teams across strategic and operational functions in a cohesive manner.
- Requires a natural ability to bring diverse teams together in a collaborative environment to achieve a common goal.
- Prior experience presenting to and influencing key stakeholders including BOD, investors, corporate partners, regulatory agencies, and KOLs is highly preferred.
- Expertise with biologics is strongly preferred.
- Must have a track record of defining and delivering on an innovative R&D strategy that has yielded critical drug development milestones.
- Gravitas and communication skills to work alongside and garner the respect across all levels of the company and external interfaces is highly preferred.
- Strategic awareness in clinical development necessary to prioritize product development opportunities to achieve the business goals is required.
- Must have superior management skills and business acumen.
- Requires a patient-centric mindset.
- Must have the desire to take a hands-on approach to advancing the portfolio.
- Experience in a fast-paced, entrepreneurial environment is required.
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.