Sr. Clinical Development Lead
Sr. Clinical Development Lead [Sr. Medical Director]
Job Type: Full-time
Salary: $260K -$290K
Location: Remote - East Coast Preference
Company Summary: A public late-stage biotech developing breakthrough receptor antagonist therapies targeting rare, life-threatening disorders, with locations in Europe and the US (Boston).
Key Responsibilities: As we help expand their Clinical Develpopment team, they are looking for Sr. Clin Dev Lead (Sr. MD) to execute clinical strategy and provide strategic leadership across Ph 1-3 programs.
The Opportunity: Join as an experienced and driven individual contributor who reports directly into the Head of Clinical Development. Drive end-to-end execution for high priority rare disease programs.
Key Responsibilities
- Develop and define short- and long-term objectives aligned with global clinical strategies, and communicate these effectively with clinical staff
- Provide strategic leadership to phase 1-3 development programs and oversee global clinical trials/trial teams on assigned programs
- Lead study protocol development, oversee study execution and final study report development
- Identify and address safety issues reported within assigned programs and develop appropriate mitigation strategies
- Participate in Clinical Team and Operations meetings, including discussion on program budgets and resource allocation
- Evaluate emerging medical and scientific data within therapeutic areas and design clinical strategies to support product development.
- Collaborate with cross-functional teams, including nonclinical and business development, to explore new therapeutic targets and indications
- Present at academic congresses, investigator meetings and advisory meetings.
- Contribute to regulatory submissions by authoring and reviewing clinical sections of submission dossiers as a medical expert, ensuring alignment with global strategies
- Conduct due diligence by evaluating clinical strategies and development plans of external partners
- Engage with external professional bodies to identify and develop key opinion leaders in assigned therapeutic areas
- Stay current with scientific advancements and provide training and guidance to team members as appropriate
Qualifications:
- MD preferably with a relevant specialization (eg: immunology, hematology, nephrology)
- 5+ years of experience of clinical research, preferably within industry, especially in rare diseases
- Regulatory experience, especially with successful IND and/or NDA submission experience preferred
- Excellent written / oral communication skills. English is company language
If you're interested, please drop a CV and we'll be in touch if it's a good fit.
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