Vice President, Clinical Development

Climb Bio, Inc; Wellesley (MA); Remote; USD 300,000 - 420,000; Full time

Benefits offered by this job

Discretionary annual bonus

Comprehensive benefits including Medical, Dental, Vision

401k company match

Generous paid time off

Equity

Job summary

A biotechnology company is seeking a Vice President, Clinical Development in Wellesley, MA to lead the clinical development strategy and execution of clinical programs. The ideal candidate will have over 10 years of experience, including 5 in leadership roles, and a strong background in regulatory submissions. The role may be remote but requires occasional travel to the Wellesley office. Competitive compensation and comprehensive benefits will be provided.

Qualifications

• Minimum of 10 years of experience in clinical development within biotechnology or pharmaceutical.
• At least 5 years in a leadership role.
• Extensive experience in immune-mediated diseases.

Responsibilities

• Develop and implement the clinical development strategy.
• Lead design, planning, and execution of clinical trials.
• Oversee clinical sections for regulatory filings.
• Build and lead a high-performing clinical development team.
• Analyze trial data and ensure robust data management and reporting.
• Manage the clinical development budget and align with timelines and goals.
• Communicate progress to the executive team, board and investors.
• Collaborate with R&D, Regulatory Affairs, CMC and operations for seamless integration.

Skills

Leadership and team management

Clinical trial design and execution

Communication and interpersonal skills

Regulatory submission experience

Cross-functional collaboration

Education

M.D. or equivalent

Board certification in Rheumatology, Immunology, Nephrology, or Hematology

Job description

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, 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 and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.

At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We are seeking an experienced clinical leader with a strong background in clinical development and a proven track record of advancing therapies from early stage development through late stage clinical trials. Reporting to the Chief Medical Officer, the Vice President, Clinical Development will play a pivotal role in driving the clinical strategy and ensuring the successful execution of our clinical programs.

Key Responsibilities:

• Develop and implement the clinical development strategy in alignment with the company’s overall objectives. Provide strategic direction and oversight for all clinical development activities.
• Lead the design, planning, and execution of clinical trials, ensuring they are conducted in compliance with regulatory requirements and industry standards.
• Oversee the preparation and submission of clinical sections for regulatory filings (INDs, NDAs, BLAs, etc.). Engage with regulatory agencies to address clinical development-related questions and issues.
• Build and lead a high-performing clinical development team. Foster a collaborative and innovative culture that emphasizes scientific excellence and patient-centricity.
• Oversee the analysis and interpretation of clinical trial data. Ensure robust data management and reporting practices are in place.
• Develop and manage the clinical development budget, ensuring efficient use of resources and alignment with project timelines and goals.
• Communicate clinical development progress and outcomes to internal and external stakeholders, including the executive team, board of directors, and investors.
• As part of the leadership team, work closely with other departments, including R&D, Regulatory Affairs, CMC, and operations to ensure seamless integration of clinical development activities.

Qualifications:

• M.D. or equivalent required; board certification in Rheumatology, Immunology, Nephrology, or Hematology preferred.
• Minimum of 10 years of experience in clinical development within the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role.
• Extensive experience in designing and executing clinical trials for immune-mediated diseases or related therapeutic areas.
• Proven track record of successful regulatory submissions and interactions with regulatory agencies.
• Strong leadership and team management skills, with the ability to inspire and motivate a high-performing team.
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, cross-functional environment.
• Strategic thinker with strong problem-solving abilities and a results-oriented mindset.This position may be based out of our Wellesley, MA office or in the greater Seattle area as a remote position.

This position may be remote or based out of our Wellesley, MA office. Remote candidates will be expected to travel on-site to Wellesley from time to time.

Base salary offered may vary depending on the individual’s skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.

Climb 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.