Associate Director/Director, Clinical Program Lead

• Partner with Clinical Development, Regulatory, CMC, Data Management, Biostats, Safety, and Quality to deliver program milestones and ensure continuity and consistency across the programs.
• Lead selected initiatives to enhance operational scalability, consistency, and inspection readiness as programs advance toward late-stage development.
• Represent Clinical Operations in asset-level planning and governance discussions.
• Support operational readiness for regulatory milestones and inspections.
• Support the development and ongoing management of strategic partnerships, helping to build effective, collaborative relationships with key external collaborators.

• Provide matrix management of clinical operations team members, may manage and develop direct reports, holding team accountable for results and values aligned behaviors.
• Set priorities, balance workloads, and step in as needed to ensure delivery.
• Provide ongoing coaching, feedback, and performance management as needed.

• Lead operational status reporting for assigned asset, including timelines, risks, and trade-offs.
• Ensure inspection-ready TMF and compliance with ICH-GCP, SOPs, and regulatory requirements across asset studies.
• Support audits, inspections, and continuous improvement initiatives.

• Contribute to or lead the design and implementation of scalable clinical operations frameworks, including governance models and sponsor oversight systems.
• Drive standardization across asset studies to enable efficient scaling of the clinical portfolio.
• Partner with Clinical Operations leadership to scale the Clinical Operations function as the pipeline grows.

• Bachelor’s degree, preferably in life sciences or a related field.
• Associate Director Level candidates will have at least 10 years of clinical operations experience and Director level candidates will have at least 12 years of clinical operations experience; including hands on trial management.
• At least 3 years of experience in a small biotech
• Demonstrated experience overseeing CROs and vendors, and building external development partnerships, ensuring alignment with global standards and regulatory expectations
• In-depth knowledge of clinical research processes, GCP guidelines, and regulatory requirements
• Excellent communication and interpersonal skills with a focus on managing external relationships effectively
• Proficiency in MS Office Suite
• Ability to travel occasionally (approximately 15%)

• Strategic planning: Ability to lead a critical program or domain with autonomy; at the Director level directs the operational strategy of the program and is accountable for its performance.
• Problem Solving & Judgment: Works on complex, ambiguous problems with limited precedent; exercises independent judgment across methods and evaluation criteria; translates development strategy into functional plans.
• Collaboration & Influence: Builds strategic partnerships across the organization and with external parties; identifies and mitigates cross-functional friction early; reconciles competing viewpoints and is seen as a connector and go-to thought partner.
• Highly organized with attention to detail and commitment to quality
• Ability to work effectively with external partners in a dynamic, fast-paced environment

This role has the option of being remote or hybrid based out of our office in Wellesley, MA.

Base salary offered may vary depending on individual’s skills, experience, and competitive market value.

• Salary Range: Associate Director: $174,000-$235,000 Director: $193,000 - $260,000
• Associate Director: $174,000-$235,000
• Director: $193,000 - $260,000

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.

Climb is a publicly traded company.

For more information, please visit climbbio.com .

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.