Associate Director, Analytical Development

Who We Are

The company is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. The company’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.

The Role

The Associate Director, Analytical Development, is responsible for leading analytical activities across the company’s development portfolio and commercial product. This role within CMC will partner closely with Regulatory CMC, Quality, and external CDMOs to ensure analytical data, reports, methods, specifications, and regulatory-supporting documentation are accurate, phase-appropriate, and aligned with program objectives. The successful candidate will provide technical leadership in the review, interpretation, and communication of analytical results while ensuring high-quality documentation supports development, commercialization, and global regulatory submissions.

Responsibilities

• Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation.

• Review analytical data packages supporting release testing, stability studies, drug substance, intermediates, and drug product manufacturing activities.

• Partner closely with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of analytical documentation and reports.

• Support analytical method development, validation, qualification, transfer, and lifecycle management activities across development and commercial programs.

• Author, review, and manage technical documents including analytical methods, validation protocols and reports, specifications, trend reports, and regulatory submission documentation.

• Coordinate analytical reporting activities for drug substance and drug product stability programs and ensure data are accurately documented and communicated.

• Support the preparation and review of CMC sections for regulatory submissions, responses to health authorities, and other regulatory filings.

• Participate in analytical investigations related to deviations, OOS, OOT, and laboratory events, ensuring documentation meets quality and regulatory expectations.

• Collaborate with external laboratories and CDMOs to ensure analytical deliverables are scientifically sound, compliant, and aligned with program timelines.

• Drive continuous improvement initiatives focused on analytical reporting processes, data integrity, document quality, and operational efficiency.

Qualifications

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• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with 8+ years of relevant industry experience, OR Master's degree with 10+ years of experience, OR Bachelor's degree with 12+ years of experience.

• Experience in analytical development, analytical reporting, CMC technical writing, or related pharmaceutical development functions.

• Strong understanding of small molecule analytical development, method validation, method transfer, stability testing, specifications, and control strategies.

• Demonstrated experience authoring, reviewing, and approving technical documents including analytical methods, protocols, reports, and regulatory-supporting documentation.

• Experience reviewing analytical data generated by CDMOs, CROs, and external testing laboratories.

• Working knowledge of analytical techniques such as HPLC/UPLC, GC, dissolution, spectroscopy, mass spectrometry, wet chemistry, particle size analysis, and related pharmaceutical characterization methods.

• Familiarity with ICH, FDA, EMA, and other global regulatory requirements related to analytical development and CMC documentation.

• Strong scientific writing, data interpretation, problem-solving, and project management skills.

• Excellent verbal and written communication skills with the ability to effectively communicate complex technical information to diverse audiences.

• Proven ability to work effectively within a cross-functional matrix organization and build strong relationships with internal stakeholders and external partners.

• Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment.

Preferred Qualifications

• Experience supporting late-stage development or commercial programs.

• Experience contributing to IND, NDA, MAA, or other global regulatory submissions.

Salary Range

$185,000 - 215,000 USD

Target Bonus: 20%

Exact compensation will vary based on skills, experience, and location.

Our Locations

Waltham, MA: Our  headquarters is located in the Greater  Boston  life sciences   community, with  an open , collaborative office environment designed   to support teamwork and connection. Employees  benefit  from convenient on-site amenities, including free  on-site parking and gym facilities in the building.

Boulder, CO:  Our Boulder location is home to  the company’s  discovery research organization and a key scientific hub with strong leadership  based on site . Situated in the greater Denver-Boulder  biopharmaceutical corridor , this office plays  a central role  in advancing our discovery efforts and  pipeline .

Our Offer  To  You

At the company, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that  se t s us apart .   We cover 100% of medical, dental, and vision premiums for you and your family,  and  help  reduce  out-of-pocket costs by funding up to 75% of in-network deductibles .  Our benefits also include  a 401(k) match with immediate vesting ,  generous paid time off,  12 weeks  of fully paid parental leave, paid  family  and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to  20 week s .   A dditional   perks  like   wellness  programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce.  We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law.  All employment is decided on the basis of qualifications, merit, and business  need .