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Associate Medical Director/Medical Director, Clinical Development

Posted Oct 07, 2019

Job Title: Associate Medical Director/Medical Director, Clinical Development

Location(s): Boston, MA

Posted Oct 07, 2019

Job Title: Associate Medical Director/Medical Director, Clinical Development

Location(s): Boston, MA

Company Overview

Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital and Pfizer that relentlessly finds paths through complexity to bring real progress and new treatment options to people living with neurological and neuropsychiatric disorders.

Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction.

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives.

Cerevel aspires to develop and nurture a culture characterized by respect, trust, curiosity, compassion with a relentless focus on mission and results. Our patient- centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring his/her own unique thinking and approach to Cerevel while sharing our core values and convictions.

Role Summary

Reporting to a Senior Medical Director, within Global Clinical Development, the Medical Director/Associate Medical Director will support early and late stage clinical development programs. The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple studies. Activities will include advancing high priority clinical programs and trials through clinical study design and execution, medical oversight and medical / clinical development. The individual who assumes this position will interact with multiple stakeholders within Cerevel, external stakeholders in the medical community as well as with global regulatory authorities. They will need to be skilled and fully engaged in the development of clinical trial designs, execution, data reviews and interpretation, as well as development of clinical study reports with a cross-functional team.

Key Responsibilities

Will support the overall clinical strategy of early and late stage assets, clinical and scientific development activities, including trial design and execution and development of expert panels
Provide medical leadership and support for programs and trials that integrate the individual’s knowledge in basic science, drug development, and medical practice with input from the medical community around the world
Will serve on one or more study management teams as a clinical development functional area leader, participating in all aspects of trial execution as required, including presenting at clinical study investigator meetings, monitoring and reviewing incoming data, engaging with study physicians, reviewing final data outputs and other activities as needed
Provide ongoing medical expertise and medical oversight of clinical trials, including eligibility evaluation and toxicity management, in conjunction with external and internal partners
Will be part of a team responsible for authoring a variety of trial related documents (eg, investigator brochures, responses to regulatory authorities and institutional review boards, clinical study reports)
Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice
May interface with key medical experts and represent the team at regulatory interactions, medical congresses and conferences
Provide medical content expertise to internal and external stakeholders
Develop and maintain relationships with program counterparts such as Research, Regulatory, Clinical Operations, Statistics, Medical Affairs and Commercial.
Contribute to the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development

Required Qualifications

Medical degree (M.D./D.O or equivalent) required
Minimum of 1year of documented experience in the pharmaceutical industry (biopharmaceutical industry or CRO) related to clinical research programs, medical monitoring, and registration activities required
Possesses the ability to critically evaluate medical/scientific information; propose new concepts and innovative ideas in drug development
Ability to design, develop, and execute clinical programs and trials in the CNS therapeutic area

Desired Qualifications

Clinical Development experiences in neurology or psychiatry is a plus

Education

Medical degree (M.D./D.O or equivalent) required

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Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

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