Medical Director Clinical Development Rare Autoimmune Nephrology
Medical Director Clinical Development Rare Autoimmune Nephrology
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1 Vacancy
Job Description
We are seeking a highly motivated and experienced Medical Director (MD) to support development activities for our portfolio our immunology clinical programs with a specific emphasis on severe immunemediated diseases related to glomerular kidney disease. Reporting directly to the Clinical Development Lead the MD is a key member of the clinical development team supporting the development of our novel therapeutic candidates in latestage studies. The successful candidate will primarily be involved in activities associated with the design monitoring data interpretation and reporting of clinical studies evaluating novel therapies across target indications. Additional responsibilities involve managing external collaborations gaining comprehensive knowledge of the literature related to the product(s) in development supporting Regulatory interactions and supporting Medical Affairs and Commercial colleagues.
As part of a startup environment the role involves extensive matrix interactions with colleagues from various disciplines to ensure the successful of clinical development plans and regulatory filings.
What You Will Do
Support the design and of clinical development plans for HIBios programs within rare autoimmune and nephrology therapeutic areas ensuring alignment with strategic objectives and timelines
Provide medical and scientific oversight for clinical trials including protocol development study monitoring data review and analysis
Collaborate with Clinical Operations in trial setup conduct recruitment activities closeout and reporting
Draft and coordinate completion of clinical study reports
Prepare responses to questions from Ethics Committees and Health Authorities
Support integrated document development for marketing authorization filing
Interpret report and prepare oral and written results of product research in collaboration with senior clinical personnel in preparation for health authority submissions
Support preparation for FDA Advisory Committee and EU Oral Explanation
Provide leadership to crossfunctional project teams with peers from clinical operations biometrics clinical pharmacology biomarker sciences regulatory affairs and medical writing and others
Establish and maintain relationships with key opinion leaders and clinical investigators in the nephroimmunology field and disease areas related to clinical development programs
Ensure compliance with regulatory requirements and guidelines
Collaborate with crossfunctional teams
Participate in due diligence activities and provide medical expertise in support of business development initiatives as needed
Represent externally at scientific conferences investor meetings and other industry events
Who You Are
You have significant experience in clinical trials and can strongly communicate and present relevant clinical data to leadership and core teams. You are curious creative and collaborative with a passion for improving the lives of patients with Rare Autoimmune Nephrology.
Qualifications :
MD or equivalent degree with board certification in nephrology immunology or similar field.
Minimum of 3 years of clinical development experience in the pharmaceutical or biotechnology industry with a track record of successful drug development.
Experience in latestage drug development with a preference for experience in nephrology and/or immunoinflammatory indications
Strong knowledge of clinical trial design and including experience with adaptive trial designs and biomarkerbased approaches
Deep understanding of regulatory requirements for drug development including experience leading interactions with global regulatory agencies
Excellent communication skills with the ability to effectively communicate complex medical and scientific information to diverse audiences
Strong interpersonal skills with the ability to establish and maintain relationships with key opinion leaders clinical investigators and internal stakeholders through a highly collaborative approach
Ability to travel domestically and internationally approximately 1020 of the time.
The base compensation range for this role is $187000 $312000. Base salary is determined by a combination of factors including but not limited to job related years of relevant experience internal equity and location of the job. Additionally this role is eligible for participation in Biogens LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear shutdown and 401K participation and matching contributions.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
