About IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We are committed to exploring how the unique structure and binding properties of the IGM antibody can improve outcomes for patients with these serious conditions. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visit www.igmbio.com.

Imvotamab in Autoimmune and Inflammatory Diseases

Imvotamab is a bispecific T cell engaging IgM antibody targeting CD20 and CD3 proteins. We believe that Imvotamab, with its 10 binding units for CD20, may successfully bind to CD20 expressing B cells with more power (avidity) compared to an IgG bispecific antibody with only one or two binding units for CD20. Our preclinical studies suggest that Imvotamab may offer the potential for deeper depletion of B cells, including those in low CD20 expressing cells, than currently approved antibody therapies. We are evaluating Imvotamab in Phase 1b clinical trials of Imvotamab in severe systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and idiopathic inflammatory myopathies (myositis).

Position Summary

IGM Biosciences is seeking a Senior Medical Director of Clinical Development, Autoimmunity, who will help develop, lead, and drive the clinical development strategy of the company’s current and future pipeline of Autoimmunity medicines. This person will serve as a key IGM AI senior management team member and actively participate in strategic planning, partnering discussions, and presentations to the Board of Directors. The position will simultaneously be a senior leadership (SLT) member of the IGM Clinical Research & Development team, who will help oversee the growth of the clinical research infrastructure at IGM.

The Senior Medical Director of Clinical Development, Autoimmunity, is responsible for the strategy and effectiveness of the clinical development programs, ensuring that they meet key milestones and quality and safety standards required by medical and regulatory agencies. She/he will lead clinical operations, biostatistics and data management, and drug safety/pharmacovigilance in Autoimmunity. The Senior Medical Director of Clinical Development, Autoimmunity, will work closely with peers to develop and implement IGM Biosciences’ product portfolio strategy with the ambition to be capable of bringing products to regulatory filings and product approval.

In the process, ensure that development goals set for the product portfolio are achieved on time and within budget.This person will also represent IGM Biosciences to medical and scientific audiences, KOLs, and medical and regulatory groups, addressing the medical and scientific aspects of the company’s autoimmunity product portfolio. Together with the leadership team, the Senior Medical Director of Clinical Development, Autoimmunity, is responsible for product development strategy, planning, and implementation for the IGM Biosciences autoimmunity product portfolio and meeting key yearly goals. The Senior Medical Director of Clinical Development at Autoimmunitymust be a strong leader with demonstrated operational excellence in a hands-on, get-it-done environment.

The position requires building strong relationships with other IGM Biosciences management team members, key board members, KOL/investigators, consultants, and advisors.

Responsibilities:

Develop IGM Biosciences' clinical and operational strategy concerning autoimmunity medicines.
Provide medical vision and clinical leadership for the strategy and plan to advance IGM Biosciences’ clinical portfolio to registration and beyond.
Develop required tools, systems, staff, and external relationships to be able to conduct all aspects of the clinical development and registration of the company’s autoimmunity products to the highest industry standard and regularly provide information to the CEO and executive leadership and make recommendations on strategy, planning, and implementation of operations.
Act as a primary spokesperson for the Company’s clinical autoimmunity programs with key opinion leaders at medical and scientific conferences and advisory boards, building and maintaining relationships consistent with the Company’s development and commercial objectives.
Work with the executive team to appraise autoimmunity business development opportunities, undertake due diligence activities, and perform strategic and operational analysis.
Ensure autoimmunity clinical development programs meet quality and safety standards required by medical and regulatory agencies, providing leadership to medical affairs and drug safety/pharmacovigilance.
Collaborate with colleagues in discovery research and preclinical development line functions to move product candidates for entry into clinical investigations.
Work with commercial and business development to evaluate product candidates, determine product indications, and design post-marketing studies.
Represent the Company with regulatory and medical agencies, globally addressing their product portfolio's scientific and medical/health aspects.
Establish, promote, and ensure the team performs to the highest standards in global safety management, as well as quality assurance.

Qualifications:

Level commensurate with experience
Minimum 10 years’ experience in global clinical drug development in leading positions in the pharma industry.
Previous experience in drug development in the autoimmunity area is required.
MD or MD/Ph.D. preferably with a specialty or experience in autoimmunity medicine.
Experience from early-stage clinical development to late-stage phase 3 trials and product approvals, preferably with significant experience in a pharma company with an autoimmunity portfolio.
Excellent understanding of pharmaceutical processes, cGCP/cGLP requirements, quality assurance, regulatory, legal, medical/health care guidelines, and other drug development and registration aspects.
Experience in clinical portfolio management, assessments, prioritizations, and of people and project management.
Critical competencies for success in this role include a transparent and inclusive leadership style, results orientation, functional competency in all aspects of autoimmunity clinical drug development, scientific rigor, and uncompromising commitment to quality.
The ideal candidate should be articulate and creative, with excellent collaborative, analytical, communication, managerial, and supervisory skills.
Proactively working at the Senior Staff level with team members from different experiences and cultures.
Must be a team player with executive presence and demeanor, excellent written and oral communication skills, and outstanding analytical abilities.
Must be comfortable working internally and externally with technical and medical experts to provide input into future drug development strategies.
Must be an independent, self-motivated individual with a highly entrepreneurial style, self-awareness, self-confidence, and a positive management style.
Must have strong interpersonal skills and be able to work effectively with all people at every level.

$275,000 - $349,999 a year

The above range reflects the typical annual salary range for this role, plus eligibility for cash and equity incentives.

This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.

Actual individual pay is determined by demonstrated experience and internal equity alignment.

We offer a fast-paced, collaborative, team-based work environment.

One of our top priorities is to maintain our employees' and their families' health and well-being. To achieve this goal, we offer comprehensive benefits with a variety of options:

Medical, dental, and vision insurance.

IGM covers the full premium amount for our employees and their dependents

FSA (Flexible Spending Account) or HSA (Health Savings Account)

STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance

Voluntary Life Insurance and Disability

401(k) Plan with Employer Match

3 Weeks of Paid Time Off, 5 sick days per year, 12 holidays

Cell phone & internet subsidy

Employee Referral Bonus Program

Annual training budget for professional development

Commuter Benefit

Annual bonus program

New hire equity

Annual refresh grants

ESPP (Employee Stock Purchase Plan)

IGM is an equal opportunity employer that prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will be considered for employment.

Apply for this job

IGM Biosciences, Inc. remote jobs

Sr. Medical Director, Autoimmunity

Director / Sr. Director, Regulatory Affairs, Immunology