Medical Director Clinical Development Immunology
Medical Director Clinical Development Immunology
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1 Vacancy
Job Description
About This Role:
As a Medical Director Clinical Development Immunology you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. In this dynamic role you will play a critical part in shaping and advancing clinical programs particularly in the lupus and autoimmune disease space. Reporting to the Executive Director you will be instrumental in crafting the clinical development strategy and leading the of complex clinical trials. Your leadership will not only impact the direction of clinical studies but also contribute to the broader objectives of the organization. Your expertise will be pivotal in bridging research and clinical operations ensuring that the needs of patients are at the forefront of innovation and that the treatments developed meet the highest standards of efficacy and safety. Joining our team means taking on a role where your contributions significantly affect our mission to transform patient care in the realm of Immunology.
What Youll Do:
- Report directly to the Executive Director Clinical Development Immunology overseeing the clinical development activities within Immunology.
- Collaborate with the Research Unit to facilitate the progression of projects into Phase I and Proof of Concept (PoC) clinical activities.
- Contribute to and review clinical study documents such as Clinical Study Protocols (CSPs) Clinical Study Reports (CSRs) Investigators Brochures (IBs) Patient Information Sheets/Informed Consent Forms (PIS/ICFs) and Statistical Analysis Plans (SAPs) along with regulatory submissions like INDs and Briefing Books (BBs).
- Monitor analyze and interpret safety and efficacy data from ongoing clinical trials.
- Serve as a clinical science expert for clinical study teams Contract Research Organizations (CROs) and study sites.
- Engage in crossfunctional clinical study team meetings providing valuable insights and direction.
- Develop and deliver impactful presentations to internal teams and external stakeholders.
- Foster relationships with key external and internal stakeholders and contribute to decisionmaking panels.
- Offer clinical scientific expertise to support business development initiatives including due diligence processes.
Who You Are:
You are a visionary in the world of clinical development driven by a passion for delivering transformative treatments to patients and healthcare systems. You possess a natural curiosity that compels you to ask probing questions and the courage to drive innovation. Quality and ethical standards are your compass; youre meticulous in your work insisting on excellence. Data is your ally guiding your decisions and helping to explore how technology can accelerate progress in research and development. Youre a team player who thrives in collaborative environments yet youre also capable of standing on your own with strong problemsolving skills and analytical acumen.
Qualifications :
Required Skills:
- MD or equivalent medical degree with a preference for specialization in rheumatology dermatology or immunology.
- A minimum of five 5 years of clinical research experience within an academic or industry setting encompassing phases I through IV.
- At least three 3 years experience in all facets of clinical trial in the pharmaceutical industry including planning reporting and publication.
- Demonstrated ability to forge scientific partnerships with key internal and external stakeholders.
- Comprehensive understanding of Good Clinical Practice (GCP) clinical trial methodology statistics and the regulatory and clinical development landscape.
- A distinguished history in the field of immunology encompassing both clinical and basic research.
- Autonomy in working environments complemented by the ability to collaborate across functions and exceptional skills in problemsolving conflict resolution and analysis
#TD1
Additional Information :
The base salary range for this position is $202000.00$278000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and longterm incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social wellbeing; including but not limited to:
Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short and LongTerm Disability insurance
A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31
Up to 12 company paid holidays 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10000 per calendar year
Employee Resource Groups participation
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
Company Industry
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
