Director, clinical pharmacology job description

The Mersana Clinical Pharmacology Group is growing, and we are looking for a clinical pharmacologist who is interested in supporting the development of our novel ADC portfolio to treat Cancer. In this role, you will have an opportunity to engage with translational pharmacology teams as they prepare INDs, work to set the First in Patient dosing strategy, and then continue to be part of the development function to support programs as they move from Phase 1 to pivotal phase and BLA filings.

You would positively impact Mersana by bringing your strategic thinking and quantitative analysis skills and approaches to help answer the critical questions on how to develop our ADC molecules, by the characterization of PK/PD data that will guide the optimal dose and schedule for patients. In this role you will form close partnerships with the non-clinical development functions such as pharmacology/DMPK and Toxicology, while being part of the boarder clinical development organization. You will be interfacing directly with and guiding the company executives on the results of your analysis and be making recommendations based from it.

You will also learn about our novel ADC technology and platforms and so help us build a good reverse translational understanding from the clinical experience so helping the selection and optimization of future discovery development targets. To be successful, you will have previously worked as a quantitative clinical pharmacologist in support of oncology development and ideally have had prior ADC experience, while having been involved in the development of both small molecule and biologic therapeutics would be a requirement. This role reports to the VP, Head of Clinical Pharmacology and you will be part of the Clinical Development Department at Mersana. You will be joining a small but growing team and will be an individual contributor as the Clinical Pharmacology representative on several of our ADC projects. Further, by joining now will allow you an opportunity to offer input on how the group should continue to expand.

How do you know if you're the right fit?

Ideally, you will have prior clinical pharmacology experience with ADC development in oncology, though having worked in clinical pharmacology developing both small and large molecules will be essential. You are familiar with the concept of model-informed drug development.

Additionally, you will:

• Be responsible for scoping, planning, and designing the needed PK and PD assessments and analysis over all phases of development.
• Use your expertise in hands on Modeling and Simulation by running exploratory analysis with standard software tools such as Phoenix Winnolin/NLME and nonlinear mixed effect programs such as NONMEM, Monolix and/or R, and be able to deploy mechanistic modeling approaches where possible. You will also be expected to drive and oversee such work with external consultants and vendors.
• Be great at communicating the results from such model approaches and be effective in advocating for model based, quantitative decision making.
• Bring your experience with PK/PD analysis with regulatory authorities, being able to address their questions verbally and in writing.
• Be familiar with relevant bioanalysis methods for both small molecules and biologics.

The other stuff

This role is best suited for Ph.D. or Pharm.D. candidates in the discipline of Clinical Pharmacology, PK/PD and/or Pharmacometrics in the pharmaceutical or biotechnology industry; typically requiring 2-5 years to acquire the experience necessary to fulfill the requirements of the job.

Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.

The Associate Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and quantitative translational pharmacology deliverables from early (pre-IND) through late-stage development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive modeling inclusive of population and statistical-based, and mechanistic and
translational-focused
approaches. This is a highly visible and team-facing role.

Primary Responsibilities Include:
Drives the development and execution of the quantitative pharmacology strategies across all stages of development (non-clinical to product registration) Leads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reports Responsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical development Serves as functional lead for global regulatory strategies and regulatory documents Maintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums.

Desired Skills and Education :
PhD in Pharmaceutical Sciences, mathematics/engineering or related field with minimum of 3 to 5 years of experience working in clinical pharmacology or pharmacometrics Strong understanding of clinical pharmacology principles, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactions Excellent communication, multitasking, and collaboration skills
#LI-Remote

This position requires once a quarter meetings on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

• MS, PharmD or PhD in pharmacometrics, pharmaceutical sciences, mathematics, statistics, or related field
• Minimum 7 years of bio/pharmaceutical experience in Clinical Pharmacology and Pharmacometrics
• Strong communication and project management skills will be essential to thrive within cross-functional teams
• An established track record of scientific project management, and an ability to lead multiple initiatives in a dynamic and fast paced environment
• Hands on experiences drafting clinical pharmacology documents (protocols, CSRs, etc.) and clinical pharmacology sections of regulatory submission documents (IBs, NDAs, briefing materials, etc)

Overview

Our Karyopharmers live and demonstrate our ICARE Values every day!

#ThisIsWhyKPTI

Karyopharmers are passionately driven in our mission to positively impact patients' lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A fun, collaborative, work environment
• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (Stock options and RSU's-at time of offer and annual awards) - we are partners in prosperity!
• Peace of mind through best in class medical (deductible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), and tuition reimbursement.
• Generous PTO and Holidays - we encourage you to recharge and spend time with family and friends.
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development programs, and a variety of reward and recognition programs)
• Cell phone allowance

*Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment

* This position is eligible for remote/hybrid working arrangement (may work from home/virtually; may also work hybrid on-site-virtual as required/approved by hiring manager.

ABOUT KARYOPHARM

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