Sr Director, CMC

Job Description

Director / Sr. Director, CMC (Head of Chemistry) - Remote

A clinical-stage biotech advancing a focused portfolio of novel targeted therapeutics is hiring a Director / Sr. Director of CMC to build out and lead its chemistry function. This is a hands-on leadership role owning small-molecule CMC end to end: synthetic route development, process optimization, scale-up, and external GMP manufacturing from discovery through IND-enabling and early clinical filings. The near-term portfolio spans targeted small-molecule conjugates, radioligands, and peptides.

Position Summary

The research and development team is seeking a Director / Sr. Director, CMC to lead the preclinical and clinical development of novel targeted therapeutics. The core of this role is synthetic route development, process optimization, scale-up, and GMP manufacturing of small molecules through external CDMOs and consultants. You will oversee the synthesis and purification of small molecules, peptides, and bio-conjugates, guide initial discovery chemistry, and manage scale-up optimization and the production and characterization of reference standards.

A key near-term priority is managing clinical supply for a radiopharmaceutical (radioligand) asset entering the clinic, alongside route optimization and IND preparation for a following program. You will own clinical supply planning, manage the supply chain, and work closely with nonclinical teams to evaluate activity in relevant disease models. You will oversee the on-site chemistry lab with at least one direct report, and lead the negotiation, selection, and oversight of external CDMOs for GMP manufacturing and release of Drug Substance and Drug Product.

What We're Really Looking For

This role sits at the intersection of traditional process chemistry and targeted-therapeutic modalities. The strongest candidates will bring:

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• Core (priority): Deep traditional small-molecule process chemistry: synthetic route development, process optimization, scale-up, and GMP manufacturing through external CDMOs. This is the foundation of the role.
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• Purification: Hands-on understanding of RP-LC (reverse-phase chromatography) for purification and isolation. This is critical across our molecules and treated as essential.
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• Clinical supply: Proven ability to plan and manage clinical supply for early-phase assets, including CDMO oversight and on-time delivery of GMP material.
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• Modality adjacency (strong plus): Experience with small-molecule drug conjugates, radioligands/radiopharmaceuticals, ADC payload-linkers, or peptide conjugates. Most of our chemistry is traditional organic synthesis; solution-phase peptide chemistry is the next most broadly applicable skill. Direct radioligand experience is a bonus, gaps here can be supplemented with consultants.
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• Build orientation: Comfort operating lean and building a function from the ground up, initially hands-on with one direct report, growing the team as programs advance.
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Key Responsibilities

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• Strategic Leadership: Direct CMC activities across the portfolio, providing scientific and technical leadership over multiple projects from early discovery through early clinical filings.
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• Route & Process Development: Lead synthetic route development, process optimization, scale-up, and GMP manufacturing of drug substance and drug product through external partners.
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• Clinical Supply Management: Own clinical supply planning and execution for early-phase assets, ensuring uninterrupted, on-time, in-budget delivery of GMP material to clinical sites.
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• Vendor Management: Identify, evaluate, select, and manage CROs, CDMOs, and consultants, including contract negotiation, budget management, and timeline oversight with a focus on quality and risk mitigation.
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• Regulatory (CMC): Oversee the writing and updates of CMC documents for regulatory filings (INDs, IMPDs) and relevant sections of Investigator Brochures and Clinical Protocols.
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• Compliance & Quality: Ensure activities comply with FDA, EMA, and ICH requirements, cGMP, and safety standards, and partner with Quality to qualify and monitor vendors.
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• Team Leadership: Lead and mentor the on-site chemistry lab and its scientists, fostering a collaborative, innovative environment.
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• Collaboration: Work across discovery, nonclinical and clinical development, regulatory, and external partners to ensure seamless progression of drug candidates.
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• Present Programs: Present data and findings to the Board, Scientific Advisory Board, regulatory agencies, strategic partners, and company leadership.
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• Budget Management: Anticipate and execute strategic operating plans, allocate resources, set priorities, and keep monthly spend in line with budget.
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Qualifications

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• PhD in organic chemistry, medicinal chemistry, or a closely related discipline, with strong knowledge of organic synthesis.
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• Minimum 10 years in drug discovery and/or development, with at least 5 years in an industry leadership role.
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• Minimum 5 years managing manufacturing programs for clinical development.
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• In-depth experience in synthetic route development, process optimization, and scale-up / large-scale manufacturing with external CDMOs (domestic and international).
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• Hands-on working knowledge of RP-LC for purification and isolation (essential).
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• Experience with small-molecule drug conjugates, ADC payload-linkers, radiopharmaceuticals/radioligands, or peptide conjugates highly desirable; solution-phase peptide chemistry a plus.
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• Familiarity with analytical techniques used to characterize small molecules.
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• Broad understanding of cGLP/cGMP, compendia testing, ICH, FDA, and EMA guidelines for pharmaceutical development and manufacturing; TGA and other agency experience a plus.
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• Excellent leadership, communication, and interpersonal skills, with the ability to operate hands-on in a fast-paced, lean, dynamic environment.
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