Takeda logo
Takeda

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Associate Director, Medical Review

Medical DirectorMedical DirectorFull TimeRemoteLeadTeam 10,001

Location

United States

Posted

5 days ago

Salary

$169.4K - $266.2K / year

Seniority

Lead

No structured requirement data.

Job Description

Associate Director, Medical Review

Takeda

Role Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Medical Review. This is a Remote based position. As an Associate Director, Medical Review within US Medical, you will be empowered to deliver high-quality, balanced and timely medical and scientific information regarding assigned products and serve as a technical and/or operational resource. In this role, you will contribute to Takeda’s mission. A typical day will include: Position Objectives: - Deliver high-quality, balanced and timely medical and scientific information regarding assigned products and serve as a technical and/or operational resource. - Provide advanced medical and scientific review for promotional materials, press releases, and sales training communications. - Provide advanced medical and scientific review for non-promotional medical materials and others as identified. - Serve as an experienced medical and scientific resource to internal stakeholders, including Medical Team(s), Brand Team(s), Regulatory Advertising and Promotion, Legal and others. Position Accountabilities: - Actively participates, supports, and contributes to assigned Medical, Regulatory, and Legal cross-functional teams in promotional review. - Serves as an experienced medical resource and collaborator for other non-medical internal stakeholders as it pertains to medical review and/or other identified commercial and corporate needs. - Grant formal approval via signature authority for the cross-functional promotional review activities including: - Providing strategic scientific consults on brand messages and content. - Reviewing promotional materials for content and accuracy. - Coordinating the development, review, and approval of clinical data on file to support promotional claims. - Maintains current awareness on industry standards and regulations, shares insights and applies best practices to promotional review and other related activities. - Provide medical review for identified medical and other non-promotional materials as requested. - Maintains current knowledge of assigned disease state, product, competitors, and other relevant medical and scientific developments. - Participates in assigned medical, brand, or company related meetings as requested. Qualifications - Have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry. - 3-5 years of healthcare or related experience (managed markets, clinical practice, research or academic) following award of doctoral degree including a minimum of 2 years of medical communications experience within the pharmaceutical industry. - Possesses advanced communication skills, both oral and written, and able to engender trust and respect of peers, subordinates and superiors. - Well-versed in highly technical and scientific languages to communicate with key internal and external stakeholders. - Firm understanding of the drug development process including key phases, processes, and techniques utilized for both pre- and post-marketing research studies. - Proven track record of teamwork, leadership, timely decision making and results orientation in meeting objectives. - Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook. Requirements - Desired therapeutic area experience. - Clinical, research, or teaching experience. - Board Certification in therapeutic area of interest. - Completion of pharmaceutical industry related residency or fellowship. Benefits - U.S. Base Salary Range: $169,400.00 - $266,200.00. - U.S. based employees may be eligible for short-term and/or long-term incentives. - Participation in medical, dental, vision insurance, a 401(k) plan and company match. - Short-term and long-term disability coverage, basic life insurance. - Tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits. - Eligible to receive up to 80 hours of sick time per calendar year. - New hires are eligible to accrue up to 120 hours of paid vacation.

Related Categories

Related Job Pages

More Medical Director Jobs

Part TimeRemoteTeam 11-50H1B Sponsor

• Accompany Health Med-Psych Associate Medical Directors (AMDs) are key clinical leaders supporting patients and care teams across our Standard and Complex Care models. • You will work with health advocates, physicians, nurses, behavioral health clinicians, and pharmacists to deliver coordinated, whole-person care for patients with complex medical, behavioral, and social needs. • As a Med-Psych AMD, you will clinically supervise Med-Psych and Psych APCs and their care pods in partnership with APC Managers, the Executive Medical Director of Integrated Clinical Services, and BH Managers. • You will also provide virtual mental and physical health care via video, phone, and text. • In the Standard Model, you will lead integrated behavioral health services for patients with mild to moderate mental health and substance use needs, using the evidence-based Collaborative Care Model. • You will act as the psychiatric consultant, supported by Med-Psych APCs and behavioral health clinicians, and collaborate with primary care and APCs to deliver patient-centered, measurement-based, treatment-to-target care. • You will also supervise med-psychiatric APCs providing e-consults for diagnostic clarity and medication management. • In the High-Risk Advanced Behavioral Health Model, you will provide direct and consultative care for a small panel of patients with serious mental illness and/or severe substance use disorders. • You will supervise and support Med-Psychiatric APCs delivering both primary medical and behavioral health care, ensuring multidisciplinary care plans that reduce avoidable utilization and increase patients’ healthy days at home.

United States
Full TimeRemoteTeam 10,001+Since 1988H1B Sponsor

• Identifying and maintaining a list of medical/therapeutic area experts, investigator targets and associated plans of action • Establishing, fostering, cultivating and maintaining relationships with KOLs in Hematological Malignancies • Act as the primary clinical/scientific resource for information pertaining to disease state and our products ensuring awareness and understanding • Participates in the development and management of company sponsored clinical trials • Establishing scientific relationships with investigators and internal Medical Affairs, supporting investigator-initiated study (IIS) concept program • Identifying relevant insights on research developments, treatment landscape to shape medical strategy • Identifies gaps in research needs and creates opportunities by collaborating with potential and existing investigators and site personnel • Responds to requests for information related to study indications, disease state and therapeutic area, and presents/discusses scientific/clinical data • Attend medical conferences collecting and reporting relevant, scientific, clinical, & competitive intelligence • Ensures company policies, procedures, principles and financial controls are maintained with integrity and professionalism is displayed internally and externally

California
$176.1K - $287.3K / year

Director of Clinical Quality and Compliance

Monogram Health

Monogram Health is a healthcare company based in Brentwood, Tennessee, focused on transforming kidney and primary care through innovative and personalized in-ho

• Monitor daily clinical quality indicators, trends, and exceptions across all care settings • Ensure adherence to evidence-based clinical standards, policies, workflows, and audit expectations • Provide real-time guidance and escalation support for quality, safety, and workflow concerns • Oversee daily compliance with federal, state, and accreditation requirements (e.g., CMS, state boards) • Lead preparation and readiness efforts for audits; serve as a primary point of contact during reviews • Maintain policies, procedures, and documentation aligned with evolving regulatory standards • Track, investigate, and resolve compliance issues, incidents, and clinical remediation plans • Lead continuous quality improvement initiatives using data, root cause analysis, and best practices • Develop, maintain, and monitor quality dashboards and key metrics • Provide leadership, coaching, and guidance to quality, compliance, and clinical support staff • Support education and training related to quality standards, compliance expectations, and regulatory updates • Communicate quality and compliance performance to executive leadership with clear insights and recommendations • Partner closely with Clinical Operations Audit, Legal, and Compliance to drive aligned and efficient oversight.

United States
Job Closed
Spyre Therapeutics logo

Senior Medical Director, Clinical Development

Spyre Therapeutics

Engineering for new heights in the treatment of inflammatory bowel disease

Full TimeRemoteTeam 11-50H1B No Sponsor

• Contribute strategic leadership and medical expertise to the clinical development of our cutting-edge antibody portfolio in rheumatic indications. • Contribute to the study design, execution and interpretation of results, with a focus on proof-of-concept and later phases of development. • Work closely with cross-functional teams including Biostatistics, Regulatory Affairs, and Clinical Operations to support integrated and strategic trial execution. • Provide scientific/medical content and other input as appropriate for INDs, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Ensure compliance with regulatory standards and guidelines, including health authority requirements for MD sign-off on patient-related matters. • Ensure the safety of study participants by actively participating in safety monitoring and data review processes. • Represent the Clinical Development function in interactions with regulatory agencies, investigators, KOLs, and other external stakeholders, as appropriate.

United States
$343K - $365K / year