Medical Director - Nephrology Clinical Development

Location United States
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Salary: Excellent salary, bonus, benefits and access to lucrative stock option scheme
Contact name: Stuart Gilboy

Contact email: stuart.gilboy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21033
Published: about 1 month ago
Expiry date: 12 April 2021

Location: Cambridge, MA or Remote - USA

​A growing biotechnology business in Cambridge, MA is working to address complications of kidney disease with current medicines and early and late phase developments based on Nobel prize winning science. Medical Director – Nephrology Clinical Development is responsible for the medical aspects of development activities, including clinical development plans (CDP) and clinical trials. The Medical Director will support the direction, planning, execution, medical oversight and interpretation of clinical trials or research activities of one or more clinical development programs. As appropriate, may be required to lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.

  • Lead/support lead the implementation of a clinical development program(s) aligned to the overall company developmental strategy. Predicated on strong medical and scientific knowledge and principles, including understanding of compliance and regulatory requirements supporting clinical input into the development process.

  • Provide/support/oversee project-related education of investigators, study site personnel, and study staff

  • Proactively input into and, as appropriate, lead clinical study teams, monitoring overall study integrity, alongside review, interpretation, and dissemination of data pertaining to safety and efficacy of the molecule

  • Present at scientific, medical and regulatory meetings globally

  • Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, key medical experts (KMEs), and patient advocacy groups

  • Input into key activities in support of the company’s planned NDA submissions. Author clinical sections for INDs, NDAs, and other related documents

  • Actively partner with pharmacovigilance to assess the safety profile of compounds

  • Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, KMEs, investigators and internal stakeholders

  • Review and author manuscripts and collaborate with cross-functional colleagues and KMEs to meet publication plan objectives

  • Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards

  • May participate in or, as appropriate, lead clinical development contributions to due diligence or other business development activity

  • As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies

Required Experience
Basic Qualifications

  • Medical Doctor (M.D.), or non-US equivalent of M.D.

Preferred Qualifications

  • Pharmaceutical drug development preferred but motivated new to industry candidates considered

  • Completion of a residency program strongly preferred

  • Completion of a subspecialty fellowship is desirable

  • Experience in Nephrology, Cardiology, and/or Hematology preferred with a strong foundation in clinical practice

  • Prior experience supporting an NDA and/or global submissions unless new to industry

  • Self-starter with the ability to run a complex clinical research program independently or part of a team depending on experience

  • Knowledge of clinical trial methodology, either from an industry or academic perspective, together with the regulatory and compliance requirements governing clinical trials

  • Experience in development of clinical strategy and the design of study protocols

  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team

For more information on this role and the company please forward an up-to-date resume or send your details to stuart.gilboy@rbwconsulting.com

Salary: Excellent salary, bonus, benefits and access to lucrative stock option scheme