Please note the following:

• The title may be set at Director, Senior Director or Vice President, depending on experience

• This position will most likely be hybrid

About Mucommune and its female reproductive health pipeline (“Elleon”):

Mucommune LLC, is a highly successful R&D organization that has incubated technologies supported by >$120M in funding since its inception. A major focus at Mucommune is the combination of both cutting edge mAb engineering and drug delivery to advance a pipeline addressing major unmet needs in female reproductive health. The lead programs are in non-hormonal contraception, with large animal efficacy & safety data as well as clinical validation of the approach in surrogate efficacy trial). The female reproductive health area has been supported by >$25M over the last 6 years, with the first two programs entering IND-enabling studies and the third anticipated to do so by mid-2027. We have secured non-dilutive funding for clinical evaluation of first two assets in the pipeline, with top line surrogate efficacy readout from Phase 1/2a anticipated for the lead program in 2H 2029. We are in the process of spinning off these assets into Elleon Biopharma, to prepare for the transition of the female reproductive health pipeline into a clinical stage company with either venture and/or large pharma backing.

Position Summary:

The Senior Director of Development will report to the Chief Executive Officer (or in the absence of a CEO, the Vice President of Operations), and dotted line to the Chief Scientific Officer. The Senior Director will serve as the operational leader of Mucommune's Development activities in the female reproductive health space, leading the execution of various CMC and non-clinical activities to advance the company's lead assets into IND filing and clinical development. There is already considerable infrastructure as well as personnel with decades of highly relevant R&D experience in place to support daily operations. The Senior Director will work in close partnership with the CSO, CEO, CMO, VP Operations to shape the company's development strategy and day-to-day execution, as well as contribute to the scientific narrative that supports fundraising and business development. This is a single-incumbent role: the Senior Director both sets CMC strategy and is the sponsor-side lead for day-to-day execution with the contract manufacturers and testing laboratories. Three workstreams run in parallel and are a hard requirement for this role: the drug substance CDMO (cell line transfer, non-GMP tox lot and GMP clinical batch), the lyophilization CDMO (cycle development, GMP lot, release and stability) and the drug product and device developer for the vaginal tablet and the capsule-in-ring vaginal ring.

Essential Duties and Responsibilities:

• Lead day-to-day execution of the company's nonclinical, bioanalytical and CMC development programs, serving as a single point of accountability for study design, data quality and timeline / budget adherence

• Manage and mentor a team of research scientists and associates, including performance management (setting goals, training, evaluating performance), and professional development. Lead efforts to expand team on an as-needed basis, including recruiting, onboarding and training. 

• Collaborate with the VP Operations, CSO, CEO and other senior leaders to refine or enhance the company's R&D operational efficiency and quality  

• Design and oversee in vitro and in vivo studies as needed that support IND-enabling development

• Ensure research programs are executed on schedule, within budget, and in compliance with applicable GLP, GMP, and regulatory standards. Work closely with Director of Regulatory Affairs and/or any Regulatory Affairs consultant and Quality consultant to ensure the work can support regulatory submission and clinical advancement. 

• Own the R&D budget end-to-end: build annual and program-specific budgets, track spend against milestones, and maintain the financial discipline required in a capital-constrained startup environment 

• Identify, evaluate, select and manage the CRO and CDMO network, and hold each vendor accountable for cost, quality and schedule: issue and evaluate RFPs, negotiate scope and price, run vendor qualification, and act as the sponsor's day-to-day technical contact, including person-in-plant attendance, review of batch records and deviations, and management of change orders. Given the company's stage, this includes building parts of the vendor ecosystem from scratch in collaboration with the VP Operations.

• Contribute to the preparation of research reports, regulatory submissions, grant applications, and scientific publications.

• Lead the authoring of the nonclinical sections, and oversee the CMC sections, of the IND, Investigator's Brochure, and regulatory briefing documents

• Own development and validation of the immunogenicity and PK assays (anti-drug antibody, including neutralizing, anti-sperm antibody, and sensitive PK/TK) with the bioanalytical CRO, in time for each IND filing

• Lead the nonclinical safety program, including reproductive and male-partner safety (penile irritation and local toxicity, tissue cross-reactivity in male reproductive tissues), with CROs and the regulatory lead

• Oversee CMC strategy across drug substance, the lyophilized intermediate, the vaginal tablet and the vaginal ring, including drug substance quantity planning, stability and tox-to-clinical comparability

• Own design controls and risk management for the vaginal ring as a drug-device combination product (ISO 14971 risk file, mechanical testing, extractables and leachables, ISO 10993 biocompatibility), working with the device developer and the device consultant

• Track NIH-funded development spend against grant-year budgets and support rebudget requests and progress reports, with the VP Operations

• Foster a culture of scientific excellence, collaboration, and open communication within the development team.

• Demonstrate intellectual honesty about negative data, willingness to cancel programs that aren't working, and comfort with the pace and ambiguity of a small company

• Manage the operational separation of programs and materials from Mucommune: oversee transfer of cell lines, reagent inventories, SOPs, data packages, and ongoing studies to ensure continuity during the Elleon spinout transition

• Ensure the wet lab infrastructure is sufficient and appropriate to support the necessary development activities: equipment procurement/qualification, EHS compliance, quality, documentation, etc. 

Qualifications/Requirements:

• PhD in immunology, pharmacology, bioengineering, biochemical engineering, pharmaceutical sciences or a closely related field, or equivalent industry experience.

• Minimum of 12+ years of experience in the biotechnology or pharmaceutical industry, with a strong record of accomplishment in research and preclinical drug development.

• Demonstrated expertise in therapeutic antibody R&D, particularly preclinical development leading to IND filing.

• Successful track record in advancing products into and through clinical development, including experience leading cross-functional project teams that have advanced candidates into the clinic. Track record of successful IND filings: contributed meaningfully to at least one IND submission that resulted in FDA clearance

• Hands-on leadership of biologics GMP campaigns at external CDMOs is essential: upstream and downstream process transfer, batch record review, deviation and investigation management, release and stability programs, and formulation development. Experience acting as the sponsor's lead on two or more GMP campaigns is expected.

• Hands-on experience designing and executing in vitro and in vivo toxicology studies and interpreting complex data sets.

• Success managing CRO relationships and working with collaborators.

• Experience with PK, PD, ADA (including neutralizing) and other immunogenicity assay development, validation and analysis in support of clinical development activities.

• Experience in reproductive immunology or women's health indications is strongly preferred 

• Experience in operating a small lab in an early-stage biotech (Series A/B) or startup environment is preferred. The candidate must demonstrate comfort with the resource constraints, pace, and ambiguity of a small lab/company — not just familiarity 

• Experience with mucosal drug delivery (e.g. inhaled, vaginal) is strongly preferred

• Experience with drug-device combination products (design controls, ISO 14971, ISO 10993) is an advantage

• Proven ability to recruit, develop, and retain scientific talent in a collaborative team environment.

• Good knowledge of GLP, GMP and GCP regulatory requirements

• Excellent written and verbal communication skills with the ability to present complex scientific data clearly and persuasively to both technical and non-technical audiences.