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Chief Medical Officer

Reference Number: 3278
Location: MA

Fairway Consulting Group has been retained to fill the Chief Medical Officer position with a rapidly growing pharmaceutical company engaged in the development and commercialization of novel therapies for pain and musculoskeletal conditions.

 

POSITION SUMMARY: 

The Chief Medical Officer will lead the company in all clinical matters and will have expert knowledge of the company’s products and their clinical utilization. Responsibilities will include providing medical expertise on cross-functional teams, providing clinical support for the commercial organization, and building scientific relationships with internal and external experts, as well as advocacy with professional societies, KOLs, and guidelines groups. This position will lead the company’s efforts across clinical development, clinical operations, data management, biostats, drug safety/pharmacovigilance, and medical affairs.

ESSENTIAL FUNCTIONS:  

  • Direction of clinical development strategy and processes within the company to ensure efficient, high quality therapeutic development programs, based on rigorous scientific, medical, and regulatory standards.
  • Accountability and ownership 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).
  • Medical monitoring of clinical research studies.
  • Oversee the Medical Affairs group including their field-based team, Medical Information, and other supporting functions.
  • Oversee the drug safety/pharmacovigilance efforts and prepare the organization for the management of commercial and clinical stage assets.
  • Provide strategic and operational guidance in the management of the company’s R&D playbook.
  • Function as a clinical expert in the evaluation of early stage assets.
  • Assist in maintaining key opinion leader relationships consistent with commercial and development objectives.
  • Direction of peer-reviewed abstract and manuscript preparation and presentations.
  • Ongoing interpretation of clinical safety and efficacy results for regulatory and pharmacovigilance purposes.
  • Collaborate with potential or current global pharmaceutical partners to ensure products are properly positioned in designated regions.
  • Support company and all current and future products with proactive engagement of key influencers (including KOLs, health system administrators, societies, and governmental agencies), in the utilization of company products and the external research and guidelines that affect them.
  • Serve as a company spokesperson regarding all clinical/medical matters.  Lead company resources in addressing laboratory, clinical, and patient product-related inquiries.
  • Interact with the Regulatory team. Assist in developing and reviewing all submissions to regulatory authorities (e.g., Meeting Packages, Pre-Market Approval application, & clinical components of other regulatory correspondence) and represent the company at key meetings.
  • Maintain knowledge of and comply with Good Clinical Practice (GCP) specifications as practiced in different geographies.
  • Personnel management responsibilities:
    • Attract, assess, retain, and develop highly competent, experienced clinical personnel who meet rigorous standards of team spirit, creativity, and technical depth.
    • Setting of clear, focused, challenging targets that allow highly skilled and appropriately empowered clinical professionals to accomplish significant business objectives consistent with departmental goals.
    • Create and encourage an environment that stresses open, candid, and timely feedback relative to performance.
    • Participate in a fast paced, results-oriented environment where the candidate’s knowledge and skill will be leveraged company-wide.
    • Share medical expertise with counterparts in other functional areas such as Manufacturing, Quality, Regulatory Affairs, R&D, Legal, and Business Development.
  • Continuously develop and maintain a "state of the art" level of knowledge of developments and trends in drug development.
  • Contribute to the development of the company's overall infrastructure and growth strategy.
  • Create and communicate a compelling vision inside and outside the Company that generates excitement, credibility, and support of the clinic research mission.

QUALIFICATIONS:

  • MD or equivalent degree required.
  • Prior experience or sub-specialty training in Pain, Orthopedics, or Rheumatology is strongly preferred.
  • Prior experience as a Chief Medical Officer strongly preferred.
  • Prior experience working in a small/emerging company strongly preferred. 
  • Prior experience launching products is strongly preferred.
  • 12+ years of experience in a biotechnology or pharmaceutical company performing most or all of the responsibilities of this position is highly preferred.
  • Outstanding writing skills.
  • Outstanding drug development track record with history of advancing multiple assets through development and commercial milestones. 
  • Track record of innovation and creativity with novel approaches to drug development strategies.
  • Track record partnering with commercial teams to build value of commercial assets.
  • Strong scientific publication record.
  • Demonstrated knowledge of GCP rules and regulations.
  • Excellent leadership skills; self-direction, requiring only strategic guidance; good judgment in handling difficult situations.
  • Teamwork oriented.
  • Well-developed interpersonal skills.  Interest in working in a multicultural and cross-functional environment.
  • Good organizational, time management, interpersonal, and conflict resolution skills. Resourceful with demonstrated management and tactical planning skills. Decisive and able to successfully manage multiple projects simultaneously.
  • Ability to work in a fast-paced environment with aggressive milestones and fluid goals.
  • Excellent verbal and written communication skills and public speaking skills. Ability to provide education on complex scientific/clinical issues in a crisp and clear manner to both peer and larger audiences.
  • Strong operational mindset with proven track record executing complex clinical and medical affairs initiatives.  Prior experience assembling clinical protocols that are well grounded in specific milestones and timelines. 

Personal Attributes:

  • High personal integrity.  Work with transparency and engender trust at all levels. 
  • Professional attitude, maturity, confidence, and credibility to advise and influence senior management.
  • Strong business acumen.
  • Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner.
  • Patient centric and results-oriented, working with tenacity to advance projects and deliver on pre-determined milestones.
  • Ability to work in a collaborative culture where the best ideas win regardless of their origin.
  • Persuasive, humble, inclusive, and resilient with a strong sense of urgency and entrepreneurial attitude.
  • Able to distill complex information into simple messages.
  • Comfortable with and experienced in presenting to board members, investors, potential partners, and company staff.

 

If you have the qualifications we seek for this exciting leadership, please email a copy of your resume with your contact information to us today.