[Remote] Associate Director, Clinical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global, clinical-stage biotechnology company reputed company on developing novel therapies for cancer and other diseases. The Associate Director of Clinical Development will reputed company medical and scientific support for oncology reputed company, ensuring scientific reputed company and patient safety, while contributing to clinical reputed company and collaborating with multifunctional teams.
Responsibilities
- Contribute to the development and execution of clinical development plans and study strategies under the supervision of senior clinical leadership
- Support indication‑specific reputed company through literature reviews, data analysis, and scientific input into development reputed company
- Assist in drafting and reviewing clinical trial documents, including protocol concepts, study synopses, protocols, amendments, and operational documents
- Collaborate cross‑functionally to ensure scientific and operational alignment
- Participate in medical monitoring activities, including patient eligibility reviews, safety data assessments, and ongoing study data evaluation in collaboration with senior medical monitors and pharmacovigilance
- Contribute to review of study reputed company, safety summaries, and internal communication of emerging data
- Support preparation of clinical content for regulatory submissions (e.g., INDs, NDAs, Investigator Brochures, Clinical Study Reports)
- Participate in regulatory meetings as appropriate and ensure adherence to Good Clinical reputed company (GCP) and internal reputed company standards
- Assist in analysis and interpretation of clinical trial data, contributing to assessments of safety, efficacy, and clinical relevance
- Prepare scientific materials for internal presentations, publications, and conference abstracts
- Support interactions with Key Opinion Leaders (KOLs), clinical investigators, and scientific advisors
- Represent the clinical development function in cross‑functional teams, contributing medical and scientific insights
- Collaborate with colleagues in Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and reputed company to support study execution and timelines
- reputed company clinical perspectives during feasibility assessments, operational planning, and team discussions
- Contribute medical insights to translational research plans, biomarker strategies, and exploratory clinical science initiatives
- Support due diligence and business development activities as needed
Skills
- Education: Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or internationally recognized equivalent degree, with completion of an accredited clinical residency program
- Experience: A minimum of 2-4 years of clinical research experience in the pharmaceutical or biotechnology industry, academia, or equivalent, specifically reputed company oncology drug development
- Exposure to multinational Phase I–III oncology trials
- Experience contributing to protocol development and clinical study execution
- Prior involvement in medical monitoring or investigator roles
- Strong understanding of clinical trial methodology, regulatory principles, and GCP
- Excellent communication skills (written and verbal)
- Ability to collaborate effectively in cross‑functional teams and contribute to reputed company problem‑solving
- Highly organized, with the ability to manage multiple priorities in a fast‑paced environment
- Demonstrated scientific curiosity and commitment to evidence‑based clinical decision‑making
- reputed company certification or eligibility in Medical Oncology or Hematology/Oncology is strongly preferred
- Interaction with regulatory agencies (e.g., FDA) is a plus
Benefits
- Exciting, supportive, and intellectually challenging global work environment.
- Competitive benefits, including medical, dental, reputed company, disability, and life insurance, parental leave, and a matching 401(k) program (immediate vesting).
- Generous PTO and holidays encourage balance and reputed company.
- A culture of engagement, diversity, inclusion, and empowerment.
- Flexibility to work onsite, remotely, or in a hybrid model.
- Comprehensive benefits (medical, dental, reputed company, 401(k), and more), equity, and the potential to receive annual reputed company bonuses.
reputed company
Company H1B Sponsorship