Director, Clinical Program Management

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. • R e s pon si b l e fo r p la n n i n g , o v e rsig h t a n d e x e c ut i o n o f assig n e d c li n i c al p r o grams : r e s pon s i b le fo r t i m e li ne s , b u d g e t , a n d k e y de li v e r a b les as w e ll as c o nt r i b ut i n g t o o v e rall c li n i c al s t r a te g y . • P ar t i c i p a te s o n C li n i c al T e ams as o pe r a t i o n al r ep r e s ent a t ive, partnering closely with Clinical Science, Biostatistics, Regulatory, Medical Affairs, Translational Medicine, and other functions to shape and execute integrated clinical development plan • R e s pon si b l e fo r p r o j e c t b ud g e t/ r e s o u r c e p la n n i n g , r e - fo r e c a s t i n g, 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. • Provides strategic input and oversight in development of clinical plans, protocols, SAPs, consent form development, and other program/study related documents. • Works with clinical outsourcing, legal, and finance in the selection of CROs and vendors, and participates in contract and budget negotiations. • Manages relationships and establishes 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 . • P r o vi de s o v e rsig h t fo r p r o j e c t- r e la t e d d a t a i n te g r a t i o n /te c hn o l o gy a c t i v i t i e s i n c l ud i n g I V R S, e P RO , c e nt ral la b , et c al on g w i t h d a t a ma n ag e m e n t d e p ar t m e n t. • P r o vi d es oversight a n d s u p po r t t o direct reports f ostering talent development, performance management, and a culture aligned with Alkermes leadership expectations and values. 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. P h y s i c a l D ema nd s a n d Wor k En vi ron me n t : Ability to t rav e l domestically a n d i nte r n a t i on ally ( u p t o 20%) Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the 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. 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. Additional details can be found on our careers website: #LI-MB1