Senior Medical Director, Clinical Development
About Climb:
Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our lead product candidate, budoprutug, is an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy.
Reporting to the SVP of Clinical Development, the Senior Medical Director will lead a cross-functional program team, and be accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access. They will also work closely with all members of the Research and Development teams to support pipeline product development and strategy. The qualified candidate needs a strong understanding of the compliance framework for clinical development activities and has an innovative drive to help the organization succeed and bring new cures to life.
Climb is a publicly traded company with teams in Boston and Seattle.
Key Responsibilities:
- Develop the Clinical Development Plan in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval and market access for one or multiple indications
- Lead the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including IND/CTA and regulatory responses) with high quality and consistency with the CDP.
- Partner with Clinical Operations to provide oversight of trial execution and reach clinical milestones
- Work closely with Translational and Research team to support initiation, execution, and interpretation of data from translational studies
- May act as Medical Monitor, ensuring continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection
- As the medical expert, participating in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Clinical Operations, Data Science, Regulatory Affairs, Project Management, Research, Manufacturing, Translational Medicine), and internal decision committees
- Develop and present CRO/CRA/site training materials and present at Investigator Meetings/site initiation visits as required
- Serve as the clinical development lead to strategize and execute a development program under the guidance of the SVP of Clinical Development
- Author/review abstracts, posters, and manuscripts for publication.
- Travel internationally and domestically
Qualifications:
- MD or equivalent required
- Advanced clinical training/knowledge or clinical research experience in a medical/scientific area, preferably in either rheumatology, immunology, nephrology and/or hematology
- 5+ years of experience of clinical development/clinical research experience working in biotechnology/pharmaceutical industry
- Detailed understanding and experience in all aspects of clinical protocol development, implementation, regulatory submissions, and overall drug development
- Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of study designs is desirable.
- Experience with regulatory submissions and health authorities
- Demonstrated ability to establish strong scientific partnership with internal and external key stakeholders
- Demonstrated leadership and strong communication skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment in pharmaceutical or biotech industry or academia or clinical CRO required
- Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company, fast-paced environment.
- Marked proficiency in clinical/medical writing.
- Experience in early-stage and late-stage development programs.
- Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States and Europe.
- Self-starter who works with a sense of urgency and functions as a strong team player.
- Patient focused, passionate about science and excited about having fun while working hard.
- Highly effective communicator; written and verbal.
- Remarkable people skills to enable high individual and high team performance. Actions and thoughts will play a key role in creating a thoughtful, respectful, continuous learning, action oriented, product focused, patient minded and value seeking culture.
- Strong collaborator.
- Able to use process as an effective management tool vs. being driven by process.
- The ideal candidate will be based in Boston
Base salary offered may vary depending on individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, generous paid time off and paid holiday, and stock options. Qualified candidates are encouraged to forward their resumes to [email protected]
Climb Bio is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.