Director, Clinical Program Management

Alkermes; Boston (MA); Hybrid; USD 220,000 - 235,000; Full time

Benefits offered by this job

Competitive benefits package

Annual performance pay bonus

Job summary

Alkermes in Boston seeks a strategic leader for managing clinical programs in support of their R&D portfolio. This role involves oversight of programs across the development lifecycle, with a focus on high-quality execution and leadership.

The ideal candidate possesses at least 10 years of clinical development experience and strong leadership skills to influence cross-functional teams. The position offers a hybrid work environment with an annual salary between $220,000 and $235,000.

Qualifications

• Minimum of 10 years of clinical development experience in pharmaceutical/biotech or CRO setting.
• Proven track record of leading global, complex clinical programs.
• Ability to influence and drive alignment across cross-functional teams.

Responsibilities

• Responsible for planning, oversight, and execution of assigned clinical programs.
• Participate in Clinical Teams to shape and execute development plan.
• Establish and monitor program performance metrics.

Skills

Leadership presence

Strategic thinking

Clinical development

Knowledge of GCP/ICH Guidelines

Education

Bachelor’s Degree in life sciences or healthcare-related field

Master’s Degree preferred

Job description

Job Description

Provide strategic and operational leadership for the planning, management, oversight, and execution of clinical programs in support of Alkermes’ R&D portfolio. This role is accountable for advancing programs across the development lifecycle, including lifecycle management (LCM) initiatives and supplemental NDA (sNDA) submissions, with a focus on high-quality, patient‑centric execution.

Work Environment

This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

Responsibilities

• Responsible for planning, oversight, and execution of assigned clinical programs: responsible for timelines, budget, and key deliverables as well as contributing to overall clinical strategy.
• Participate in Clinical Teams as operational representative, partnering closely with Clinical Science, Biostatistics, Regulatory, Medical Affairs, Translational Medicine, and other functions to shape and execute integrated clinical development plan.
• Responsible for project budget/resource planning, reforecasting, milestone, payment and variance tracking with Clinical Outsourcing & Finance, and Project Management.
• Establish and monitor program performance metrics, leveraging data and insights to continuously improve execution and inform leadership decision‑making.
• Provide strategic input and oversight in development of clinical plans, protocols, SAPs, consent form development, and other program/study related documents.
• Work with clinical outsourcing, legal, and finance in the selection of CROs and vendors, and participate in contract and budget negotiations.
• Manage relationships and establish strong partnerships with CROs, vendors, investigators, and other external partners to ensure delivery of high‑quality, timely outcomes.
• Partner with the Study Start‑Up team on clinical start‑up activities including feasibility, country selection/recommendation, budget & timeline planning, supply chain, and regulatory preparation.
• Provide oversight and support to direct reports fostering talent development, performance management, and a culture aligned with Alkermes leadership expectations and values.

Qualifications

• Bachelor’s Degree in life sciences or healthcare‑related field; Master’s Degree preferred.
• Minimum of 10 years of clinical development experience in a pharmaceutical/biotech or CRO setting.
• Proven track record of leading global, complex clinical programs across multiple phases, with deep experience in Phase 4/LCM programs.
• Strong leadership presence with the ability to influence and drive alignment across cross‑functional teams.
• Excellent strategic thinking, organizational, and execution skills with the ability to manage competing priorities.
• Strong knowledge and understanding of GCP/ICH Guidelines and regulatory requirements.

Travel Requirements

Ability to travel domestically and internationally (up to 20%).

Compensation and Benefits

The annual base salary for this position ranges from $220,000 to $235,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package.

EEO Statement

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.