<p>We are seeking an Executive Director, CMC, Drug Product to join our team. The Executive Director, CMC, Drug Product manages and oversees the development and manufacturing of cGMP drug products for deployment in early- and late-stage clinical trials and commercial distribution. The Executive Director, CMC, Drug Product will be a key member of a highly collaborative internal CMC team, primarily managing programs and manufacturing campaigns through CDMOs and CROs.</p> <p>This position reports to the Senior Vice President, Pharmaceutical Sciences and will be based out of Boston, MA, USA in our Needham office. We will consider other jurisdictions for exceptional candidates. This role is a hybrid position, requiring a minimum of 2 days per week in the office</p> <p>RESPONSIBILITIES:</p> <ul> <li>Lead teams in formulation development, and manufacturing of small molecule drug products from preclinical stages through NDA approval and commercialization. </li><li>Oversee development and manufacturing processes, ensuring compliance with quality and regulatory standards. </li><li>Manage R&D activities related to preformulation, solid form, formulation, and drug product processes, including technology transfer through CDMOs or internal resources. This includes process validation and proposing specifications for excipients and finished drug products, as well as contributing to analytical method development. </li><li>Integrate preformulation and biopharmaceutics strategies within CMC to facilitate early candidate selection. </li><li>Develop and implement formulation strategies for poorly soluble small molecules using techniques such as particle size reduction, lipid-based formulations, amorphous solid dispersions, and self-emulsifying drug delivery systems. </li><li>Provide input for drug product stability programs and select appropriate packaging for clinical development and commercial use. </li><li>Evaluate, recommend, and manage qualified CDMOs for manufacturing drug products for clinical trials, scale-up, validation, and commercial use. Collaborate with Quality Assurance to manage audits and inspections of CDMOs. </li><li>Author and review core CMC documents/modules and other submissions and responses to FDA and other Competent Authorities, ensuring strategic oversight and consistency for regulatory interactions, including IND/NDA/MAA/IMPD filings and periodic updates. </li><li>Stay informed on pharmaceutical development, regulatory guidelines, and competitive trends to provide informed recommendations. </li><li>Develop and propose short- and long-term objectives for the function in alignment with overall company strategies and plans. </li><li>Collaborate with development and commercial partnerships, including ex-US collaborations, to ensure global alignment and integration of strategies. </li><li>Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans. </li><li>Plan and manage budget proposals and approved budgets in accordance with the Company's strategic and operating plans and Finance policies. </li><li>Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company's Human Resource policies and practices. </li><li>Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any </li><li>Some international travel may be required. </li><li>Other duties as assigned </li></ul> <p>QUALIFICATIONS:</p> <ul> <li>PhD in Chemistry, Pharmaceutical Sciences, Pharmaceutics, or a related discipline with at least 12 years of relevant management experience in a pharma or biotech environment. Candidates with an MSc and relevant experience may also be considered. </li><li>Extensive experience in managing development-stage drug product manufacturing activities, including oversight of external Contract Manufacturing Organizations (CMOs). </li><li>Expertise in developing solid oral and parenteral dosage forms. </li><li>Proficiency in developing and manufacturing age-appropriate pediatric formulations. </li><li>Strong background in preformulation science, solid-state characterization, physicochemical characterization, and solid-state properties of drug candidates. </li><li>Expertise in formulation development strategies for challenging molecules, including solubility and bioavailability enhancement approaches. </li><li>Demonstrated success in transitioning development assets to commercial products. </li><li>Experience contributing to and developing CMC sections in US and ex-US regulatory filings. </li><li>In-depth knowledge of cGMP regulations, guidance, principles, and best practices related to drug product development and manufacture. </li><li>Proficiency in Failure Modes Effect Analysis (FMEA) and establishment of Critical Process Parameters (CPPs). </li><li>Experience with CDMO selection, management, contracting, and issue resolution. </li><li>Excellent oral and written communication, leadership, and interpersonal skills, with the ability to build credibility and trust both inside and outside the company. </li><li>Proven ability to build and develop high-performing teams, with strong delegation and conflict resolution skills. </li></ul> <p>The base salary range for this role is $242,200 to $306,300 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.</p>