Associate Medical Director
- Support development of individual trial protocols in view of clinical development plan
- Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards
- Drive and monitor quality of all clinical documents (e.g., protocols, study reports, Investigators' Brochures, clinical components of regulatory submissions, safety documents)
- Support/lead creation/review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] for registration, market access, and commercialization of the compound(s)
- Support oversight of the safety of the drug, including the safety aspects of patients in clinical studies and signal detection
- Support the development of other relevant medical deliverables: concept sheets, briefing books, and label and marketing application dossier, clinical development plans
- Contribute to the development of the program strategy for assigned trials/compounds
- Support creation, integration, and execution of overall medical strategy of assigned clinical development programs
- Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide input to key external presentations
- Support interaction with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel methods of development
- Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge
- MD or equivalent (e.g. MBBS) degree
- Minimum of 1+ years of directly related industry experience within oncology or hematology
- Experience representing team and organization in a variety of internal/external settings
- Proven performance in earlier role/comparable role.
- Prior experience in biotech/pharmaceutical company preferred
- Prior clinical trial medical oversight experience preferred
- Prior clinical / academic experience in hematology/ oncology
- Therapeutic area knowledge/ experience for the role
- Team Player
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so!
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