Associate Director, Clinical Pharmacology - Cambridge, United States - Knewin

Knewin Cambridge, United States

2 weeks ago

Description

Company Description

Bicycle Therapeutics (

NASDAQ:
BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines.

Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need.

Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.
Culture

is key and all Bicycle employees actively embrace and role model our company values:
Weare Adventurous .We believe it'sthewaytodeliverextraordinaryresultsforourpatients.
Weare DedicatedtoourMission .Youcan'tchangetheworldifyoudon'thavedetermination.
Weare OneTeam .Weonlysucceedwhenweworktogether.
Job Description

We are looking for an Associate Director in Clinical Pharmacology who will be a key member of our multidisciplinary drug development teams.

You will serve as Clinical Pharmacology lead to design and execute the various clinical pharmacology components of the Bicycle Therapeutics clinical portfolio.

You should be familiar with current scientific best practice and regulatory guidance in clinical pharmacology, pharmacometrics, pharmacokinetics and drug metabolism.

Lead the design, planning, execution, and interpretation of Clinical and Clinical Pharmacology studies
Perform and/or guidepharmacokinetic and pharmacodynamic data analysis
Draft and/or review PK related reports (eg. NCA, population PK, exposure-response analysis)
Contribute to the design and development of Clinical Pharmacology submission documents for regulatory filings
Collaborate cross-functionally with other departments, including Clinical, Regulatory, Translational Science, Biometrics, Clinical Operation and Pharmacovigilance
Qualifications

Essential:
PharmD or PhD with a minimum of 3 years of bio/pharmaceutical experience in Clinical Pharmacology and/or Pharmacometrics
Hands-on experience designing, conducting and interpreting clinical pharmacology studies
Demonstrated expertise in preparing clinical pharmacology documents (protocols, pharmacokinetic reports, CSRs, etc.) and the preparation of regulatory documents and submissions (INDs and/or NDAs)
An established track record of scientific project management, and an ability to lead multiple initiatives in a dynamic and fast paced environment
Strong interpersonal skills and can-do attitude with flexibility and ability to adapt

Desirable:
Direct drug development experience within oncology is desired but not required
Hands-on experience on population PK/PD models, exposure-response analysis, and other standard forms of modeling and simulation, is highly desirable
Additional Information

Flexible working environment
Competitive reward including annual company bonus
Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
Health and Dependent Care Flexible Spending Accounts
401(k) plan with a 4% Company match and immediate vesting
Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
Employee assistance program
Employee recognition schemes
10 Company holidays
Competitive Family Leave Policy
Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company.

Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

#J-18808-Ljbffr

Head, Clinical Pharmacology

3 days ago

Leap Therapeutics Cambridge, United States

**Head, Clinical Pharmacology**: · **Company Summary**: · **General Responsibilities**: · ***The Head of Clinical Pharmacology will be responsible for developing and executing the clinical and non-clinical pharmacology strategies for compounds from the pre-clinical stage through ...
Head, Clinical Pharmacology

2 days ago

Leap Therapeutics Cambridge, United States

Company Summary · Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patien ...
Head, Clinical Pharmacology

3 days ago

Leap Therapeutics Cambridge, United States

Company Summary · Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patien ...
Director, Clinical Pharmacology

6 days ago

Takeda Pharmaceuticals Boston, United States

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
Director, Clinical Pharmacology

1 week ago

Takeda Boston, MA, United States

As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda's Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining ther ...
Director, Clinical Pharmacology

2 weeks ago

Takeda Boston, United States Full time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
Director Clinical Pharmacology

1 week ago

AstraZeneca Watertown, United States

Director Clinical Pharmacology & Pharmacometrics (Clinical Pharmacology)Introduction to role:Join us as a Director Clinical Pharmacology & Pharmacometrics, a scientific role that works closely with the clinical team to create a clinical pharmacology development program. This role ...
Director Clinical Pharmacology

1 week ago

AstraZeneca, plc Watertown, United States

Introduction to role:Join us as a Director Clinical Pharmacology & Pharmacometrics, a scientific role that works closely with the clinical team to create a clinical pharmacology development program. This role provides differentiated medicine and the Clinical, Director, Clinic, De ...
Associate Director, Clinical Pharmacology

2 days ago

Bicycle Therapeutics Cambridge, United States

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists ...
Associate Director, Clinical Pharmacology

1 week ago

Bicycle Therapeutics Limited Cambridge, United States

Company Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-target ...
Associate Director, Clinical Pharmacology

2 weeks ago

Bicycle Therapeutics Limited Cambridge, United States

Company DescriptionBicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted i ...
Associate Director, Clinical Pharmacology

4 days ago

Bicycle Therapeutics Cambridge, United States

Job Description · Job DescriptionCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell a ...
Associate Director, Clinical Pharmacology

3 weeks ago

Fusionpharma Boston, United States

Associate Director, Clinical Pharmacology/DMPK Management Boston, MA, USFusion is looking for an Associate Director, Clinical Pharmacology/ DMPK to join non-clinical development group.The successful candidate must have experience and foundational knowledge and experience in clini ...
Director Clinical Pharmacology

1 week ago

AstraZeneca PLC Waltham, United States

Director Clinical Pharmacology & Pharmacometrics (Clinical Pharmacology) · Introduction to role: · Join us as a Director Clinical Pharmacology & Pharmacometrics, a scientific role that works closely with the clinical team to create a clinical pharmacology development program. Thi ...
Associate Director, Clinical Pharmacology

3 weeks ago

Fusion Pharmaceuticals Boston, United States Full time

Fusion is looking for an Associate Director, Clinical Pharmacology/ DMPK to join non-clinical development group.The incumbent will be responsible to lead and execute clinical pharmacology/ DMPK strategies and studies for early through late-stage clinical development programs.The ...
Director Clinical Pharmacology

1 week ago

AstraZeneca Waltham, MA, United States

Director Clinical Pharmacology & Pharmacometrics (Clinical Pharmacology)Introduction to role:Join us as a Director Clinical Pharmacology & Pharmacometrics, a scientific role that works closely with the clinical team to create a clinical pharmacology development program. This role ...
Senior Director, Clinical Pharmacology

1 week ago

Dyne Therapeutics Inc Watertown, United States

Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...
Senior Director, Clinical Pharmacology

2 weeks ago

BioSpace, Inc. Watertown, United States

Job Details · Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligo ...
Director/Senior Director, Clinical Pharmacology

2 weeks ago

Tango Therapeutics Boston, MA, United States

Company Overview · Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. · Using an approach that starts and ends with patients, Tango leverages the genetic ...
Director/Sr. Director, Clinical Pharmacology

1 week ago

Scorpion Therapeutics Boston, MA, United States

JOB DESCRIPTION · The successful candidate will have a proven track record of working in the clinical PK/PD clinical pharmacology area supporting R&D programs. They will have experience with working in a highly collaborative team environment, interfacing with multiple department ...