|Discipline:||Medical & Pharmacovigilance|
|Salary:||£Salary: Excellent salary, bonus, benefits and access to lucrative stock option scheme|
|Contact name:||Stuart Gilboy|
|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
Medical Doctor (M.D.), or non-US equivalent of M.D.
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 email@example.com
Salary: Excellent salary, bonus, benefits and access to lucrative stock option scheme
- Lead CRA
Job location: Germany Job salary: £Salary: On application
Location: Home based Germany Do you want to ...
- Head of Non-Clinical Development
Job location: Boston Job salary: £Salary: On application
The Role: Lead the nonclinical development tea...
- Director, Head of Quality Control
Job location: Raleigh Job salary: £Salary: On application
Client: Clinical stage, cell therapy biotech Lo...