About This Role
Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To
accomplish
this, we are seeking top talent to join us on our journey.
As the Lead, Clinical Pharmacology, Immunology, you will serve
on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for
dosage regimens
,
and study designs throughout the drug development lifecycle. This position
is
located in
South San Francisco office or could be fully
Remote
.
T
he
candidate must
reside
within the USA.
What You'll Do
Provide clinical pharmacology
expertise
to program and study teams throughout a molecule’s lifecycle (discovery through development)
Provide functional representation on development program
s
and study teams
and
identify
opportunities where modeling and simulation can ad
vance the understanding of pharmacological activity,
efficacy
and safety
Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical)
Define key milestones and decisions within the clinical pharmacology development plan and
identify
risks and mitigation strategies
Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results
Conduct hands
-
o
n quantitative ana
lysis and present
the findings to multidisciplinary project teams
Serve as lead author and key contributor to clinical pharmacology sections of
documents
Serve as
the
subject matter expert in
interactions with Health Authorities
Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed
Work with program and/or study teams to achieve program goals and provide deliverables in approved
timeframes
Maintain
cutting edge
knowledge of best regulatory practices, quantitative/clinical pharmacology
methodology
, and drug development precedent
Qualifications
PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields
5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
Ability to analyze and interpret PK and PK/PD data
utilizing
sound scientific principles
Experience
with
designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies
Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm
Knowledge of and ability to apply
appropriate regulatory
and ICH guidelines
with regard to
the acquisition, analysis, and interpretation of clinical pharmacology data
Hands
-
on
experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses
Experience with Model Informed Drug Development
(MIDD) paired meeting program is a plus
Proficiency
with use of PK/PD software packages such as Phoenix, R,
NONMEM
.
E
xperience with
Monolix
and
MATLAB
is a plus
Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards
#LI-TD1
Additional Information
The base compensation range for this role is $144,000.00-$240,000.00. 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 Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established 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 life-changing 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 E-Verify Employer in the United States.
Job Level: Management
Additional Information
The base compensation range for this role is: $144,000.00-$240,000.00
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 long-term 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 well-being
; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 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 $10,000 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 mid-sized biotechnology company, we provide the stability and resources of a well-established 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 life-changing 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 Biogen.
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 E-Verify Employer in the United States.