1 день назад
Clinical Development Director, Early Development Cardiometabolic/General Medicine
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Development Director, Early Development Cardiometabolic/General Medicine (Clinical Trials/Drug Development): Leading early-phase clinical development of cardiometabolic and general medicine compounds from first-in-human studies through proof-of-concept with an accent on trial strategy, protocol development, safety and efficacy evaluation, and biomarker use. Focus on designing and implementing clinical trials, interpreting pharmacodynamic and pharmacokinetic data, preparing regulatory submissions, and aligning cross-functional development teams.
Location: United States; corporate headquarters in Thousand Oaks, California, with conditions listed in Washington, D.C.
Company
is a biotechnology company developing medicines across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead early-phase clinical development of cardiometabolic and general medicine compounds from first-in-human studies through proof-of-concept.
- Design and implement clinical development strategies, study protocols, informed consents, Investigator Brochures, and regulatory submissions.
- Review clinical study safety, efficacy, pharmacodynamic, and pharmacokinetic data.
- Develop and apply clinical biomarker strategies to support drug development.
- Collaborate with Precision Medicine, Research, Late Development, Regulatory, Safety, Commercial, and external expert teams.
- Evaluate external licensing and partnering opportunities in cardiometabolic and general medicine.
Requirements
- MD or DO degree from an accredited medical school.
- At least 2 years of industry, academic, basic science, or clinical research experience.
- Understanding of cardiometabolic and general medicine pathophysiology.
- Experience with clinical trial methodology, trial design, monitoring, implementation, and results interpretation.
- Leadership, collaboration, interpersonal, and presentation skills, including work in matrix environments.
- Publication track record and the ability to communicate with internal stakeholders and external partners.
Nice to have
- Board certification or eligibility in Internal Medicine, Cardiology, or Endocrinology.
- Residency training in Internal Medicine and a relevant subspecialty.
- At least 3 years of relevant pharmaceutical or academic drug development experience, preferably in early-stage clinical trials.
- Experience collaborating with pharmaceutical sponsors.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Award-winning time-off plans and career development opportunities.
- Flexible work models where applicable to the role.
Hiring process
- Applications are accepted until a candidate is selected or a sufficient number of applications is received.
- Sponsorship for the role is not guaranteed.
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