Vice President Medical Affairs

Adagio Therapeutics

Waltham, MA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 02/20/2021
  • Website: adagiotx.com
  • Company Address:

About Adagio Therapeutics

Developer of antibodies intended to provide an effective long-term solution for the global coronavirus challenge. The company is developing antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV-1 and additional potentially emergent coronaviruses, helping doctors with antibodies that can be used as both therapeutic and durable prophylactic treatments.

Job Description

Adagio Therapeutics is developing best-in-class antibodies that can broadly neutralize SARS-CoV-2, SARS-CoV-1 and additional potentially emergent coronaviruses. We believe our antibodies will match or exceed the potency and coverage of conventional SARS-CoV-2 antibody programs and can be used as both therapeutic and durable prophylactic treatments. Our candidates are engineered using best-in-industry antibody discovery capabilities and are designed to maximize potency and duration of effect. Our portfolio includes multiple, non-competing antibodies with distinct binding targets, enabling a strategy that can avoid viral escape. Our lead program is expected to enter the clinic in early 2021.

 

Position Title: Vice President, Medical Affairs

 

Position Summary:

Adagio Therapeutics is looking to hire an experienced Vice President, Medical Affairs to join our team. This is an exciting opportunity to join a rapidly growing, innovative company.

 

Adagio Therapeutics is seeking a passionate Vice President, Medical Affairs who will work closely with other Departments to lead the development of the Company’s medical affairs strategy. S(he) will be responsible for designing and implementing medical strategies and tactical plans while providing thought leadership and tactical execution for medical education, medical information system development, field medical liaisons, medical communication and medical publications.

 

Reporting to the Chief Medical Officer, the VP, Medical Affairs defines strategy and will develop and refine Medical Affairs policies and procedures and SOPs, to ensure and maintain excellence in standards and practices. The VP, Medical Affairs will oversee the company’s KOL advisory board management and the investigator-initiated trials program. Additionally, the VP, Medical Affairs will oversee the design and execution of phase IV studies and, when appropriate, lead the phase IV clinical programs.

 

Responsibilities:

  • Establish and lead the Medical Affairs function
  • Develop and implement the US and global medical affairs plan including oversight of medical communications, medical education, congresses/conferences, KOL outreach and advisory boards
  • Develop and refine Medical Affairs policies and procedures and SOPs
  • Work closely with commercial and clinical development/regulatory in designing and implementing launch strategies and tactics as well as life cycle planning
  • Develop strategic imperatives and tactical plans to enhance healthcare practitioner education to improve patient outcomes
  • Develop strategy for review and approval of investigator-initiated studies
  • Actively lead the design and conduct of Phase IIIB/IV trials and medical materials review

·      Establish and maintain strong working relationships with key external stakeholders (medical experts, medical societies and managed care organizations, patient advocacy groups, clinical/medical stakeholders)

·      Execute the communications plan supporting the scientific needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, supporting CME, writing of abstracts/publications, as appropriate and required). Responsible for all medical communication aspects of scientific and clinical studies, regulatory submissions, and post-approval market support

·      Oversee the planning and implementation of external exchange including conferences, industry groups, Ad Boards, etc.; develop or adapt internal strategies to reflect the output of external scientific boards.

  • Collaborate with Commercial, Legal, and Regulatory for development and review of labelling, advertising and promotional materials
  • Provide input into clinical development plans and strategies
  • Monitor the competitive environment to sustain expertise in therapeutic area including clinical management, new therapies, competitive products and features
  • Provide assessments of product opportunities and threats
  • Contribute to coaching and training Regional Medical Scientists and sales force personnel on Company clinical, medical, and scientific matters

 

Requirements:

  • Minimum of 7 years’ Medical Affairs experience within biotech/pharma
  • Advanced degree (MD, PharmD) with specialization in infectious diseases or pulmonary/critical care preferred
  • Experience developing and managing physician relationships as well as applying legal and regulatory guidelines in drug development, including knowledge of promotional regulations as they relate to drug approvals.
  • Demonstrable success working in highly matrixed, cross-functional environment requiring excellent cross functional collaboration to achieve successful results
  • Strong interpersonal skills commensurate with the need to work closely with partners, KOL's, consultants, and team members across functions
  • Strong writing and presentation skills.
  • Strong clinical/scientific background/aptitude
  • Ability to anticipate and adapt to change
  • Excellent abilities to follow complex direction/processes under pressure and proficient balancing multiple routine tasks simultaneously to achieve goals
  • Strong organizational skills, with attention to detail as well as ability to independently determine and develop approaches to non-routine problems – a self-starter.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.